Drug Recall Report

On 11/05/2025, SUN PHARMACEUTICAL recalled LISDEXAMFETAMINE DIMESYLATE 70 MG due to Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25°C, 60%RH) for Lisdexamfetamine dimesylate capsules. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LISDEXAMFETAMINE DIMESYLATE 70 MG
NDC Number: 57664005288
Lot Number: AD48712, AD50898
Expiration Date: 04/30/2026, 05/31/2026

What you should do: 

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 11/05/2025, SUN PHARMACEUTICAL recalled LISDEXAMFETAMINE DIMESYLATE 60 MG due to Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25°C, 60%RH) for
Lisdexamfetamine dimesylate capsules. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LISDEXAMFETAMINE DIMESYLATE 60 MG
NDC Number: 57664005188
Lot Number: AD48711, AD50896
Expiration Date: 04/30/2026, 05/31/2026

What you should do: 

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 11/05/2025, SUN PHARMACEUTICAL recalled LISDEXAMFETAMINE DIMESYLATE 50 MG due to Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25°C, 60%RH) for
Lisdexamfetamine dimesylate capsules. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LISDEXAMFETAMINE DIMESYLATE 50 MG
NDC Number: 57664005088
Lot Number: AD48710, AD50895
Expiration Date: 04/30/2026, 05/31/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 11/05/2025, SUN PHARMACEUTICAL recalled LISDEXAMFETAMINE DIMESYLATE 40 MG due to Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25°C, 60%RH) for Lisdexamfetamine dimesylate capsules. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LISDEXAMFETAMINE DIMESYLATE 40 MG
NDC Number: 57664004988
Lot Number: AD48709, AD50894
Expiration Date: 04/30/2026, 05/31/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 11/05/2025, SUN PHARMACEUTICAL recalled LISDEXAMFETAMINE DIMESYLATE 30 MG due to Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25°C, 60%RH) for Lisdexamfetamine dimesylate capsules. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LISDEXAMFETAMINE DIMESYLATE 30 MG
NDC Number: 57664004888
Lot Number: AD42470, AD48708
Expiration Date: 02/28/2026, 04/30/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 11/05/2025, SUN PHARMACEUTICAL recalled LISDEXAMFETAMINE DIMESYLATE 20 MG due to Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25°C, 60%RH) for Lisdexamfetamine dimesylate capsules. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LISDEXAMFETAMINE DIMESYLATE 20 MG
NDC Number: 57664004788
Lot Number: AD42469, AD48707
Expiration Date: 02/28/2026, 04/30/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 11/05/2025, SUN PHARMACEUTICAL recalled LISDEXAMFETAMINE DIMESYLATE 10 MG due to Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25°C, 60%RH) for Lisdexamfetamine dimesylate capsules. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LISDEXAMFETAMINE DIMESYLATE 10 MG
NDC Number: 57664004688
Lot Number: AD42468, AD48705
Expiration Date: 02/28/2026, 04/30/2026

What you should do: 

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 11/05/2025, BRECKENRIDGE recalled DULOXETINE HCL 60 MG due to CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: DULOXETINE HCL 60 MG
NDC Number: 51991074890, 51991074810
Lot Number: 240721C, 230286C
Expiration Date: 02/28/2027, 02/28/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 11/05/2025, TEVA USA recalled PRAZOSIN HCL 5 MG due to CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. The
U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: PRAZOSIN HCL 5 MG
NDC Number: 00093406901, 00093406952, 00093406905
Lot Number: 3010403A, 3010385A, 3010404A, 3010405A, 3010510A, 3010528A, 3010354A, 3010592A, 3010605A, 3010611A, 3010612A, 3010655A, 3010703A, 3010430A, 3010613A, 3010406A
Expiration Date: 02/2026, 02/2026, 02/2026, 03/2026, 03/2026, 03/2026, 03/2026, 08/2026, 08/2026, 08/2026, 08/2026, 02/2027, 02/2027, 11/2025, 08/2026, 02/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 10/29/2025, GRAVITI PHARMACEUTICALS recalled BUPROPION XL 300 MG due to Failed Tablet/Capsule Specifications. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: BUPROPION XL 300 MG
NDC Number: 16571086303
Lot Number: BPB124341A
Expiration Date: 10/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 11/05/2025, TEVA PHARMACEUTICALS recalled PRAZOSIN HCL 2 MG due to CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.

The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: PRAZOSIN HCL 2 MG
NDC Number: 00093406801, 00093406810
Lot Number: 3010398A, 3010399A, 3010400A, 3010401A, 3010353A, 3010439A, 3010388A, 3010526A, 3010527A, 3010591A, 3010343A, 3010352A, 3010468A, 3010469A, 3010461A, 3010629A, 3010653A, 3010654A, 3010679A, 3010702A, 3010547A, 3010402A, 3010593A, 3010610A
Expiration Date: 12/2025, 12/2025, 12/2025, 12/2025, 12/2025, 01/2026, 01/2026, 03/2026, 03/2026, 07/2026, 10/2025, 11/2025, 02/2026, 02/2026, 02/2026, 09/2026, 01/2027,02/2027, 02/2027, 02/2027, 04/2026, 02/2028, 07/2026, 09/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 11/05/2025, TEVA PHARMACEUTICALS recalled PRAZOSIN HCL 1 MG due to CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.

The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: PRAZOSIN HCL 1 MG
NDC Number: 00093406701, 00093406710
Lot Number: 3010544A, 3010545A, 3010567A, 3010590A, 3010601A, 3010602A, 3010603A, 3010652A, 3010670A, 3010671A, 3010678A, 3010700A, 3010701A, 3010440A, 3010672A
Expiration Date: 10/2025, 10/2025, 12/2025, 02/2026, 03/2026, 03/2026, 03/2026, 07/2026, 07/2026, 07/2026, 08/2026, 08/2026, 08/2026, 12/2025, 07/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 10/15/2025, ACCORD HEALTHCARE recalled LEVOTHYROXINE SODIUM 88 MCG due to Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LEVOTHYROXINE SODIUM 88 MCG
NDC Number: 16729045015
Lot Number: D2300045
Expiration Date: 12/31/2025

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 10/08/2025, APOTEX CORP recalled KETOROLAC TROMETHAMINE 0.5 % due to Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns. The U.S. Food and Drug Administration (FDA) has issued a Class
II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: KETOROLAC TROMETHAMINE 0.5 %
NDC Number: 60505100301
Lot Number: VA0444, VA4608 and TZ7016
Expiration Date: 01/2026, 01/2026 and 12/2025

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 09/24/2025, ASCEND LABORATORIES LLC recalled ARIPIPRAZOLE 10 MG due to superpotent drug. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: ARIPIPRAZOLE 10 MG
NDC Number: 67877043203
Lot Number: 24144162
Expiration Date: 09/2027

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 09/24/2025, UNICHEM PHARMA recalled CYCLOBENZAPRINE HCL 10 MG due to Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in
color).The U.S. Food and Drug Administration (FDA) has issued a Class I Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: CYCLOBENZAPRINE HCL 10 MG
NDC Number: 29300041519
Lot Number: GMML24026A
Expiration Date: 09/30/2027

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 08/20/2025, MERCK & CO. INC recalled BELSOMRA 10 MG due to Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: BELSOMRA 10 MG
NDC Number: 00006003330
Lot Number: 2090019 and 2123744
Expiration Date: 04/30/2027

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 08/06/2025, NOSTRUM LABORATORIES recalled CINACALCET HCL 90 MG due to Failed Dissolution Specifications. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: CINACALCET HCL 90 MG
NDC Number: 64380088504
Lot Number: 7715893A
Expiration Date: 12/31/2027

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 08/13/2025, ALEMBIC PHARMACEUTICALS recalled DOXEPIN HCL 10 MG due to CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. The U.S. Food and Drug Administration (FDA) has issued a Class II
Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: DOXEPIN HCL 10 MG
NDC Number: 62332063731
Lot Number: 23050515142
Expiration Date: 09/30/2025

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 08/13/2025, SUN PHARMACEUTICAL recalled SPIRONOLACTONE 25 MG due to Presence of foreign substance: identified as aluminum. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: SPIRONOLACTONE 25 MG
NDC Number: 53489014301
Lot Number: P3314
Expiration Date: 11/30/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 08/06/2025, NOSTRUM LABORATORIES recalled SUCRALFATE 1 G due to CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: SUCRALFATE 1 G
NDC Number: 29033000305
Lot Number: All Lots
Expiration Date: All Expiration Dates

What you should do: 

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 07/23/2025, ASCEND LABORATORIES recalled RIZATRIPTAN 5 MG due to CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. The U.S. Food and Drug Administration (FDA) has issued a Class II
Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: RIZATRIPTAN 5 MG
NDC Number: 67877026118
Lot Number: 23142117, 23142119, 23142122
Expiration Date: May 2026 and Jun 2027

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 07/23/2025, ASCEND LABORATORIES recalled RIZATRIPTAN 10 MG due to CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. The U.S. Food and Drug Administration (FDA) has issued a Class II
Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: RIZATRIPTAN 10 MG
NDC Number: 67877026218
Lot Number: 22143653, 22143675, 22144528, 22144977, 23140257, 23140999, 23141900, 23142118, 23142120, 23142123, 23144563, 23144565, 24142623, 24142624, 24142626, 24143469
Expiration Date: July 2025, September 2025, November 2025, December 2025, Feb 2026, May 2026, November 2026, May 2027, June 2027

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 07/23/2025, SUN PHARMACEUTICAL recalled LISDEXAMFETAMINE DIMESYLATE 60 MG due to Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH). The
U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LISDEXAMFETAMINE DIMESYLATE 60 MG
NDC Number: 57664005188
Lot Number: AD42648
Expiration Date: 02/28/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 07/23/2025, ACCORD HEALTHCARE recalled LEVOTHYROXINE SODIUM 50 MCG due to Subpotent Drug: Assay below the approved specification. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LEVOTHYROXINE SODIUM 50 MCG
NDC Number: 16729044815
Lot Number: D2300087
Expiration Date: 12/31/2025

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 07/23/2025, ACCORD HEALTHCARE recalled LEVOTHYROXINE SODIUM 25 MCG due to Subpotent Drug: Assay below the approved specification. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LEVOTHYROXINE SODIUM 25 MCG
NDC Number: 16729044717
Lot Number: D2400679
Expiration Date: 02/28/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 07/23/2025, ACCORD HEALTHCARE recalled LEVOTHYROXINE SODIUM 25 MCG due to Subpotent Drug: Assay below the approved specification. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LEVOTHYROXINE SODIUM 25 MCG
NDC Number: 16729044715
Lot Number: D2300325, D2400536
Expiration Date: 01/31/2026, 02/28/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 07/23/2025, ACCORD HEALTHCARE recalled LEVOTHYROXINE SODIUM 175 MCG due to Subpotent Drug: Assay below the approved specification. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LEVOTHYROXINE SODIUM 175 MCG
NDC Number: 16729045617
Lot Number: D2300042
Expiration Date: 12/31/2025

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 07/23/2025, ACCORD HEALTHCARE recalled LEVOTHYROXINE SODIUM 150 MCG due to Subpotent Drug: Assay below the approved specification. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LEVOTHYROXINE SODIUM 150 MCG
NDC Number: 16729045517
Lot Number: D2300076
Expiration Date: 12/31/2025

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 07/23/2025, ACCORD HEALTHCARE recalled LEVOTHYROXINE SODIUM 112 MCG due to Subpotent Drug: Assay below the approved specification. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LEVOTHYROXINE SODIUM 112 MCG
NDC Number: 16729045217
Lot Number: D2300104
Expiration Date: 12/31/2025

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 07/23/2025, ACCORD HEALTHCARE recalled LEVOTHYROXINE SODIUM 100 MCG due to Subpotent Drug: Assay below the approved specification. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LEVOTHYROXINE SODIUM 100 MCG
NDC Number: 16729045117
Lot Number: D2300092, D2400722
Expiration Date: 12/31/2025, 03/31/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 07/09/2025, MAJOR PHARMA recalled GABAPENTIN 100 MG due to Defective container; blister packaging inadequately sealed. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: GABAPENTIN 100 MG
NDC Number: 00904666561
Lot Number: M05205
Expiration Date: 10/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 07/09/2025, GRANULES PHARMA recalled METOPROLOL SUCCINATE 25 MG due to Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25C/60% RH) long-term. The U.S. Food and Drug
Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: METOPROLOL SUCCINATE 25 MG
NDC Number: 70010078001
Lot Number: 1400008A
Expiration Date: 12/31/2025

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 07/09/2025, GRANULES PHARMA recalled METOPROLOL SUCCINATE 25 MG due to Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25/60% RH) long-term. The U.S. Food and Drug
Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: METOPROLOL SUCCINATE 25 MG
NDC Number: 70010078005
Lot Number: 1400008B
Expiration Date: 12/31/2025

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 07/02/2025, TEVA PHARMACEUTICALS recalled METOCLOPRAMIDE HCL 10 MG due to the Presence of foreign tablets/capsules. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: METOCLOPRAMIDE HCL 10 MG
NDC Number: 00093220301
Lot Number: 5420094
Expiration Date: 09/30/2027

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 07/02/2025, APOTEX CORP recalled KETOROLAC TROMETHAMINE 0.5 % due to Lack of Assurance of Sterility. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: KETOROLAC TROMETHAMINE 0.5 %
NDC Number: 60505100302
Lot Number: TZ1236
Expiration Date: 11/30/2025

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 07/02/2025, APOTEX CORP recalled AZELASTINE HCL 0.05 % due to Lack of Assurance of Sterility. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: AZELASTINE HCL 0.05 %
NDC Number: 60505057804
Lot Number: VD1654
Expiration Date: 06/30/2027

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 05/28/2025, KVK TECH recalled INDOMETHACIN ER 75 MG due to cGMP deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: INDOMETHACIN ER 75 MG
NDC Number: 10702001601
Lot Number: 18400A
Expiration Date: 7/31/2027

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 06/04/2025, GLENMARK PHARMACEUTICALS recalled CARVEDILOL 6.25 MG due to CGMP Deviations; presence ‘N-Nitroso Carvedilol I’ Impurity above the recommended acceptable intake limit. The U.S. Food and Drug Administration (FDA) has issued a Class II
Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: CARVEDILOL 6.25 MG
NDC Number: 68462016305
Lot Number: 19231174, 19231199, 19231164, 19231517,19231527, 19231566, 19231568, 19231595, 19231618, 19231634, 19231638, 19231448, 19232043, 19232051, 19232064, 19232322, 19232324, 19232365, 19232380, 19232389, 19232736, 19232743, 19232746, 19232756, 19232757, 19233369, 19233371, 19233405, 19233416, 19234162, 19234183, 19234192, 19234204, 19234223, 19234243, 19234263, 19234165, 19234242, 19234743, 19234774, 19234993, 19240223, 19240203, 19240211, 19240214, 19240247, 19240249, 19240272, 19240319 and 19240543
Expiration Date: Feb-25, Mar-25, Apr-25, May-25, Jun-25, Jul-25, Sep-25, Nov-25, Dec-25 and Jan-26

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 06/04/2025, GLENMARK PHARMACEUTICALS recalled CARVEDILOL 6.25 MG due to CGMP Deviations; presence ‘N-Nitroso Carvedilol I’ Impurity above the recommended acceptable intake limit. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: CARVEDILOL 6.25 MG
NDC Number: 68462016301
Lot Number: 19233369, 19234162 and 19240543
Expiration Date: Jul-25, Sep-25, and Jan-26

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 06/04/2025, GLENMARK PHARMACEUTICALS recalled CARVEDILOL 3.125 MG due to CGMP Deviations; presence ‘N-Nitroso Carvedilol I’ Impurity above the recommended acceptable intake limit. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: CARVEDILOL 3.125 MG
NDC Number: 68462016205
Lot Number: 19231450, 19231464, 19231471, 19231493, 19232083, 19232103, 19232658, 19233328, 19233343, 19233344, 19233345, 19234275,19234843, 19235039, 19240280 and 19240296
Expiration Date: Mar-25, Apr-25, Jun-25, Jul-25, Sep-25, Nov-25 and Dec-25

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 06/04/2025, GLENMARK PHARMACEUTICALS recalled CARVEDILOL 3.125 MG due to CGMP Deviations; presence ‘N-Nitroso Carvedilol I’ Impurity above the recommended acceptable intake limit. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: CARVEDILOL 3.125 MG
NDC Number: 68462016201
Lot Number: 19231450, 19233345, 19234275 and 19240280
Expiration Date: Mar-25, Jul-25, Sep-25 and Dec-25

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 06/04/2025, GLENMARK PHARMACEUTICALS recalled CARVEDILOL 12.5 MG due to CGMP Deviations; presence ‘N-Nitroso Carvedilol I’ Impurity above the recommended acceptable intake limit. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: CARVEDILOL 12.5 MG
NDC Number: 68462016405
Lot Number: 19231899, 19231922, 19231927, 19231967, 19231979, 19232226, 19232234, 19232265, 1923227,19232758, 19232759, 19232762 and 19232788
Expiration Date: Apr-25, May-25 and Jun-25

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 06/04/2025, GLENMARK PHARMACEUTICALS recalled CARVEDILOL 25 MG due to CGMP Deviations; presence ‘N-Nitroso Carvedilol I’ Impurity above the recommended acceptable intake limit. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: CARVEDILOL 25 MG
NDC Number: 68462016505
Lot Number: 19231107, 19231114, 19231152 and 19234866
Expiration Date: Feb-25 and Jan-26

What you should do: 

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 05/28/2025, ASTTRAZENECA recalled AIRSUPRA 90-80 MCG due to Defective delivery system. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: AIRSUPRA 90-80 MCG
NDC Number: 00310908012
Lot Number: 6270044C00, 6270040D00, 6270034E00, 6270053C00, 6270045C00, 6270047C00, 6270056C00, 6270052C00, 6270063E00, 6270064C00, 6270071D00, 6270075D00, 6270075F00 and 6270107C00
Expiration Date: 10/2026, 11/30/2026, 12/31/2026 and 9/30/2027

What you should do: 

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 05/07/2025, ACCORD HEALTHCARE recalled LEVOTHYROXINE SODIUM 112 MCG due to Subpotent Drug. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LEVOTHYROXINE SODIUM 112 MCG
NDC Number: 16729045215
Lot Number: D2400725
Expiration Date: 03/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 05/07/2025, ACCORD HEALTHCARE recalled LEVOTHYROXINE SODIUM 88 MCG due to Subpotent Drug. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LEVOTHYROXINE SODIUM 88 MCG
NDC Number: 16729045017
Lot Number: D2300044
Expiration Date: 12/2025

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 05/07/2025, ACCORD HEALTHCARE recalled LEVOTHYROXINE SODIUM 50 MCG due to Subpotent Drug. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LEVOTHYROXINE SODIUM 50 MCG
NDC Number: 16729044817
Lot Number: D2400547
Expiration Date: 02/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 05/07/2025, ACCORD HEALTHCARE, recalled LEVOTHYROXINE SODIUM 25 MCG due to Subpotent Drug. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LEVOTHYROXINE SODIUM 25 MCG
NDC Number: 16729044717
Lot Number: D2300323
Expiration Date: 01/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/23/2025, EUGIA US LLC recalled TESTOSTERONE CYPIONATE 200 MG/ML due to cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the
affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: TESTOSTERONE CYPIONATE 200 MG/ML
NDC Number: 55150027701
Lot Number: 1TC24075A
Expiration Date: 11/30/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, GLENMARK PHARMACEUTICALS recalled CARVEDILOL 12.5 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: CARVEDILOL 12.5 MG
NDC Number: 68462016405
Lot Number: 17240238, 17240243, 17240245 and 17240248
Expiration Date: Jan-26, Jan-26, Jan-26 and Jan-26

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, GLENMARK PHARMACEUTICALS recalled DILTIAZEM 12HR ER 120 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: DILTIAZEM 12HR ER 120 MG
NDC Number:68462056201
Lot Number:17241067 and 17241628
Expiration Date: May-26 and Aug-26

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, SOMERSET THERAPEUTICS PRIVATE LIMITED recalled HALOPERIDOL DECANOATE 100 MG/ML due to Lack of Assurance of Sterility: Media fill with bacterial contamination. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: HALOPERIDOL DECANOATE 100 MG/ML
NDC Number:70069038310
Lot Number:A240482D
Expiration Date:08/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, GLENMARK PHARMACEUTICALS recalled LACOSAMIDE 50 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LACOSAMIDE 50 MG
NDC Number:68462067860
Lot Number:17240221 and 17240222
Expiration Date:Jan-26 and Jan-26

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, GLENMARK PHARMACEUTICALS recalled LACOSAMIDE 100 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LACOSAMIDE 100 MG
NDC Number:68462067960
Lot Number:17232533, 17232534, 17240606, 17240619, 17240911, 17240912, 17241121 and 17241124
Expiration Date:Nov-25, Nov-25, Mar-26, Mar-26, May-26, May-26, Jun-26 and Jun-26

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, GLENMARK PHARMACEUTICALS recalled LACOSAMIDE 150 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LACOSAMIDE 150 MG
NDC Number:684620680605
Lot Number:17241125, 17242202 and 17242204
Expiration Date:Jun-26, Nov-26, Dec-26

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, GLENMARK PHARMACEUTICALS recalled LACOSAMIDE 200 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LACOSAMIDE 200 MG
NDC Number:68462068160
Lot Number:17230982, 17230986, 17231001, 17240197, 17240198, 17240215, 17240846 and 17240847
Expiration Date:Apr-25, Apr-25, Apr-25, Jan-26, Jan-26, Jan-26, Apr-26 and Apr-26

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, GLENMARK PHARMACEUTICALS recalled GABAPENTIN 600 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: GABAPENTIN 600 MG
NDC Number:68462012605
Lot Number:17231015, 17231128, 17231138, 17231139, 17231143, 17231144, 17231848, 17231898, 17231977, 17231978, 17232015, 17232016, 17232017, 17232034, 17232041, 17232396, 17232406, 17232410, 17232490, 17240326, 17240327, 17240383, 17240395, 17241863, 17241869, 17241870, 17231256, 17231386, 17231387, 17231407, 17231417, 17231418, 17231754, 17240085, 17240117 and 17240131
Expiration Date:Apr-25, Apr-25, Apr-25, Apr-25, Apr-25, Apr-25, Aug-25, Aug-25, Aug-25, Aug-25, Aug-25, Aug-25, Aug-25, Aug-25, Aug-25, Nov-25, Nov-25, Nov-25, Nov-25, Jan-26, Jan-26, Feb-26, Feb-26, Oct-26, Oct-26, Oct-26, May-25, May-25, May-25, May-25, May-25, May-25, May-25, Jul-25, Dec-25 and Dec-25

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, GLENMARK PHARMACEUTICALS recalled NITROGLYCERIN 0.3 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: NITROGLYCERIN 0.3 MG
NDC Number:68462063801
Lot Number:1723236 and 17232367
Expiration Date:Nov-25 and Nov-25

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, GLENMARK PHARMACEUTICALS recalled NITROGLYCERIN 0.4 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: NITROGLYCERIN 0.4 MG
NDC Number:68462063945
Lot Number:17232024, 17232071 and 17232072
Expiration Date:Aug-25, Sep-25 and Sep-25

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, GLENMARK PHARMACEUTICALS recalled PRAVASTATIN SODIUM 20 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: PRAVASTATIN SODIUM 20 MG
NDC Number:68462019605
Lot Number:17230810, 17230811, 17230810, 17232501 and 17232502
Expiration Date:Mar-26, Mar-26, Mar-26, Nov-26 and Nov-26

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, NORTHSTAR RX LLC recalled PRAVASTATIN SODIUM 20 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: PRAVASTATIN SODIUM 20 MG
NDC Number:16714055901
Lot Number:17230810
Expiration Date:Mar-26

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, NORTHSTAR RX LLC recalled PRAVASTATIN SODIUM 80 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: PRAVASTATIN SODIUM 80 MG
NDC Number:16714055901
Lot Number:17230810
Expiration Date:Mar-26

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, GLENMARK PHARMACEUTICALS recalled PROCHLORPERAZINE MALEATE 10 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: PROCHLORPERAZINE MALEATE 10 MG
NDC Number:68462089001
Lot Number:17240254 and 17240257
Expiration Date:Jan-26 and Jan-26

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, GLENMARK PHARMACEUTICALS recalled SAXAGLIPTIN HCL 2.5 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: SAXAGLIPTIN HCL 2.5 MG
NDC Number:68462072690
Lot Number:17241788, 17241821 and 17241822
Expiration Date:Sep-26, Sep-26 and Sep-26

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, GLENMARK PHARMACEUTICALS recalled SAXAGLIPTIN HCL 5 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: SAXAGLIPTIN HCL 5 MG
NDC Number:68462072730
Lot Number:17232460, 17232460, 17241194 and 17241194
Expiration Date:Nov-25, Nov-25, Jun-26 and Jun-26

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, GLENMARK PHARMACEUTICALS recalled ROSUVASTATIN CALCIUM 40 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: ROSUVASTATIN CALCIUM 40 MG
NDC Number:68462026430
Lot Number:17240389, 17240390, 17240426, 17240427, 17240428, 17240778, 17241055, 17241074, 17241075, 17241091 and 17241100
Expiration Date:Feb-26, Feb-26, Feb-26, Feb-26, Feb-26, Apr-26, May-26, Jun-26, Jun-26, Jun-26 and Jun-26

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, B. BRAUN MEDICAL INC recalled SODIUM CHLORIDE 0.9 % due to the Presence of Particulate Matter. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: SODIUM CHLORIDE 0.9 %
NDC Number:00264220110
Lot Number:J4K936
Expiration Date:7/31/2027

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, GLENMARK PHARMACEUTICALS recalled SOLIFENACIN SUCCINATE 5 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: SOLIFENACIN SUCCINATE 5 MG
NDC Number:68462038630
Lot Number:17232395, 17232400 and 17232395
Expiration Date:Nov-25, Nov-25 and Nov-25

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, GLENMARK PHARMACEUTICALS recalled SOLIFENACIN SUCCINATE 5 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: SOLIFENACIN SUCCINATE 5 MG
NDC Number:68462038690
Lot Number:17232395, 17232400 and 17232395
Expiration Date:Nov-25, Nov-25 and Nov-25

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, GLENMARK PHARMACEUTICALS recalled SOLIFENACIN SUCCINATE 10 MG due to CGMP Deviations. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: SOLIFENACIN SUCCINATE 10 MG
NDC Number:68462038730
Lot Number:17230762
Expiration Date:Mar-25

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/16/2025, ZYDUS PHARMACEUTICALS recalled VENLAFAXINE HCL 75 MG due to the Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: VENLAFAXINE HCL 75 MG
NDC Number:68382002101
Lot Number:M314265
Expiration Date:10/31/2025

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/02/2025, Strides Pharmacy, INC recalled TESTOSTERONE 25MG(1%) due to the Presence of foreign substance: Presence of Benzene. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: TESTOSTERONE 25MG(1%)
NDC Number: 64380015102
Lot Number: 5501127A, 5501236A, 5501341A, 5501406A, 5501408A, 5501516A, 5501568A, 5501829A, 5502000A, 5502004A, 5502005A, 5502092A, 5502217A and 5502262A
Expiration Date: Apr-25, Jun-25, Jul-25, Aug-25, Sep-25, Oct-25, Mar-26, Jul-26, Aug-26, Oct-26, Dec-26 and Jan-27

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 04/02/2025, Strides Pharma, INC recalled TESTOSTERONE 50 MG (1%) due to the Presence of foreign substance: Presence of Benzene. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: TESTOSTERONE 50 MG (1%)
NDC Number: 64380015202
Lot Number: 5501103A, 5501237A, 5501238A, 5501278A, 5501280A, 5501342A, 5501372A, 5501496A, 5501499A, 5501580A, 5501582A, 5501653A, 5501656A, 5501770A, 5501842A, 5501868A, 5501882A, 5501957A, 5502001A, 5502033A, 5502112A, 5502115A, 5502180A and 5502181A
Expiration Date: Mar-25, Apr-25, May-25, Jun-25, Jul-25, Aug-25, Sep-25, Oct-25, Dec-25, Jan-26, Feb-26, Apr-26, May-26, Jul-26, Aug-26, Oct-26 and Nov-26.

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 03/12/2025, Safecor Health, LLC recalled LORAZEPAM 2 MG/ML due to Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LORAZEPAM 2 MG/ML
NDC Number: 65162068784
Lot Number: 24261384 and 24370127
Expiration Date: 03/24/2025 and 04/28/2025

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 03/12/2025, Safecor Health, LLC recalled LORAZEPAM 2 MG/ML due to Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LORAZEPAM 2 MG/ML
NDC Number: 00121077001
Lot Number: 24251067 and 24421733
Expiration Date: 03/25/2025 and 06/03/2025

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 03/12/2025, Safecor Health, LLC recalled LORAZEPAM INTENSOL 2 MG/ML due to Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of
the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LORAZEPAM INTENSOL 2 MG/ML
NDC Number: 00054353244
Lot Number: 24210274 and 24401700
Expiration Date: 01/31/2025 and 04/25/2025

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 02/26/2025, Alvogen, INC recalled FENTANYL 25 MCG/HR due to Defective delivery system – patches could be multi-stacked, adhered one on top of the other, in a single product pouch. The U.S. Food and Drug Administration (FDA) has issued a Class I Recall of the
affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: FENTANYL 25 MCG/HR
NDC Number: 47781042447
Lot Number: 108319
Expiration Date: 04/30/2025

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting https://www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 02/26/2025, Major Pharmaceuticals recalled LORAZEPAM 0.5 MG due to Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. The U.S. Food and Drug
Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LORAZEPAM 0.5 MG
NDC Number: 00904600761
Lot Number: N01424, N01425, N01659, N01660, N01668, N01679, N01704, N01745, N01856, N01973 and N02079.
Expiration Date: 03/31/2025, 08/31/2025, 09/2025, 10/31/2025, 02/28/2026, 05/31/2026 and 08/31/2026.

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 02/26/2025, Major Pharmaceuticals recalled LORAZEPAM 1 MG due to Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. The U.S. Food and Drug
Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LORAZEPAM 1 MG
NDC Number: 00904600861
Lot Number: N01419, N01420, N01421, N01663, N01664, N01673, N01688, N01747, N01748, N01749, N01792, N01857, N01974 and N02081. 
Expiration Date: 03/31/2025, 06/30/2025, 08/31/2025, 09/30/2025, 08/31/2025, 11/30/2025, 12/31/2025, 02/28/2026, 05/31/2026 and 08/31/2026.

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 1/15/2025, ENDO USA, INC recalled CLONAZEPAM 0.25 MG due to Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. The U.S. Food and Drug Administration (FDA) has issued a Class I Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: CLONAZEPAM 0.25 MG ODT TABLET
NDC Number: 49884030702
Lot Number: 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550143401, 550147201 AND 550147401
Expiration Date: 08/31/2026.

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 01/15/2025, ENDO USA, INC recalled CLONAZEPAM 1 MG due to Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. The U.S. Food and Drug Administration (FDA) has issued a Class I Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: CLONAZEPAM 1 MG ODT TABLET
NDC Number: 49884030902
Lot Number: 550145201, 550175901, 550176001 AND 550176201
Expiration Date: 08/31/2026 AND 02/28/2027

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 1/15/2025, ENDO USA, INC recalled CLONAZEPAM 2 MG due to Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. The U.S. Food and Drug Administration (FDA) has issued a Class I Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: CLONAZEPAM 2 MG ODT TABLET
NDC Number: 49884031002
Lot Number: 550176501 AND 550176601
Expiration Date: 02/28/2027

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting https://www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

On 01/08/2025, Lupin Pharmaceuticals recalled LEVOTHYROXINE SODIUM 75 MCG due to Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study. The U.S. Food and Drug 
Administration (FDA) has issued a Class II Recall of the affected medications.

More information about the recall is at: https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: LEVOTHYROXINE SODIUM 75 MCG
NDC Number: 68180096703
Lot Number: LA01276
Expiration Date: 07/2026

What you should do:

• If you have the medication, please contact the pharmacy where you got it to verify if the lot number that you received is part of this recall and for further instructions.
• Adverse events from the use of prescription drugs should be reported to FDA by visiting https://www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.