FDA Drug Recalls

676 recalls · Class II, newest first

Class II · Moderate risk Ongoing Oct 22, 2025

clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC…

Reason cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…

Zydus Pharmaceuticals (USA) Inc NDC 16714-850-01 D-0153-2026

Class II · Moderate risk Ongoing Oct 22, 2025

clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC…

Reason cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…

Zydus Pharmaceuticals (USA) Inc NDC 16714-849-01 D-0152-2026

Class II · Moderate risk Ongoing Oct 21, 2025

TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer…

Reason Defective Container

Kenvue Brands LLC D-0121-2026

Class II · Moderate risk Ongoing Oct 21, 2025

Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only…

Reason Lack of Assurance of Sterility.

Bristol-Myers Squibb Company NDC 0003-7125-11 D-0097-2026

Class II · Moderate risk Ongoing Oct 20, 2025

NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals…

Reason Failed Dissolution Specifications

Golden State Medical Supply Inc. D-0158-2026

Class II · Moderate risk Ongoing Oct 17, 2025

Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB…

Reason Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine…

Aero Healthcare NDC 55305-135-01 D-0155-2026

Class II · Moderate risk Ongoing Oct 16, 2025

Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging…

Reason Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA)…

Amerisource Health Services LLC NDC 60687-572-32 D-0103-2026

Class II · Moderate risk Ongoing Oct 16, 2025

Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging…

Reason Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA)…

Amerisource Health Services LLC NDC 68084-997-01 D-0102-2026

Class II · Moderate risk Ongoing Oct 16, 2025

Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging…

Reason Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA)…

Amerisource Health Services LLC NDC 68084-996-01 D-0101-2026

Class II · Moderate risk Ongoing Oct 15, 2025

Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir…

Reason Lack of Assurance of Sterility

ProRx LLC D-0120-2026

Class II · Moderate risk Ongoing Oct 15, 2025

Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir…

Reason Lack of Assurance of Sterility

ProRx LLC D-0119-2026

Class II · Moderate risk Ongoing Oct 15, 2025

Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir…

Reason Lack of Assurance of Sterility

ProRx LLC D-0118-2026

Class II · Moderate risk Ongoing Oct 15, 2025

Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers…

Reason Lack of Assurance of Sterility

ProRx LLC D-0117-2026

Class II · Moderate risk Ongoing Oct 15, 2025

Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers…

Reason Lack of Assurance of Sterility

ProRx LLC D-0116-2026

Class II · Moderate risk Ongoing Oct 15, 2025

Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir…

Reason Lack of Assurance of Sterility

ProRx LLC D-0115-2026

Class II · Moderate risk Ongoing Oct 15, 2025

Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir…

Reason Lack of Assurance of Sterility

ProRx LLC D-0114-2026

Class II · Moderate risk Ongoing Oct 14, 2025