FDA drug recalls
The latest medications recalled in the U.S., straight from the FDA's openFDA Enforcement database — what was recalled, why, and how serious it is. Informational only; for any product you have, follow the FDA's guidance and ask your pharmacist.
Subscribe to the recall feed (RSS) — every new recall as it lands, with the FDA's own stated reason.
Recalls by drug type
0.9% SODIUM CHLORIDE Injection
Class IILack of Assurance of Sterility: Potential for flexible container leaks.
Otsuka ICU Medical LLC · Oct 27, 2025
Lanthanum Carbonate chewable tablets
Class IIFailed stability specifications: Out of specification for hardness test
Cipla USA, Inc. · Oct 24, 2025
Lanthanum Carbonate chewable tablets
Class IIFailed stability specifications: Out of specification for hardness test
Cipla USA, Inc. · Oct 24, 2025
Bromocriptine Mesylate Capsules
Class IIFailed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Zydus Pharmaceuticals (USA) Inc · Oct 23, 2025
clomiPRAMINE Hydrochloride
Class IIcGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Zydus Pharmaceuticals (USA) Inc · Oct 22, 2025
clomiPRAMINE Hydrochloride
Class IIcGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Zydus Pharmaceuticals (USA) Inc · Oct 22, 2025
clomiPRAMINE Hydrochloride
Class IIcGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Zydus Pharmaceuticals (USA) Inc · Oct 22, 2025
Opdualag (nivolumab and relatlimab-rmbw) injection
Class IILack of Assurance of Sterility.
Bristol-Myers Squibb Company · Oct 21, 2025
TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by:…
Class IIDefective Container
Kenvue Brands LLC · Oct 21, 2025
NIACIN Extended-Release Tablets
Class IIFailed Dissolution Specifications
Golden State Medical Supply Inc. · Oct 20, 2025
Acetaminophen 500mg Caffeine 65mg caplets
Class IILabeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Aero Healthcare · Oct 17, 2025
Prazosin Hydrochloride
Class IIFailed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Amerisource Health Services LLC · Oct 16, 2025
Prazosin Hydrochloride
Class IIFailed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Amerisource Health Services LLC · Oct 16, 2025
Prazosin Hydrochloride
Class IIFailed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Amerisource Health Services LLC · Oct 16, 2025
Semaglutide Injection
Class IILack of Assurance of Sterility
ProRx LLC · Oct 15, 2025
Semaglutide Injection
Class IILack of Assurance of Sterility
ProRx LLC · Oct 15, 2025
Tirzepatide Injection
Class IILack of Assurance of Sterility
ProRx LLC · Oct 15, 2025
Semaglutide Injection
Class IILack of Assurance of Sterility
ProRx LLC · Oct 15, 2025
Semaglutide Injection
Class IILack of Assurance of Sterility
ProRx LLC · Oct 15, 2025
Semaglutide Injection
Class IILack of Assurance of Sterility
ProRx LLC · Oct 15, 2025
Semaglutide Injection
Class IILack of Assurance of Sterility
ProRx LLC · Oct 15, 2025
Testosterone 87.5 MG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone Regular Release 200 MG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone / Triamcinolone Acetonide
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone 200 MG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone / Triamcinolone Acetonide 50MG/10MCG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone Regular Release 50 MG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG)
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone 25MG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG)
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone / Triamcinolone Acetonide
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG)
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone 62.5 MG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone 50MG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone / Triamcinolone Acetonide 25MG/5MCG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Amoxicillin and Clavulanate Potassium for Oral Suspension USP
Class IISubpotent drug; Clavulanate Potassium component
Teva Pharmaceuticals USA, Inc · Oct 13, 2025
Dr. Bump Natural Pain Relief Gel
Class IICGMP Deviations
CA BOTANA International, Inc. · Oct 10, 2025
Gabriel Mineral Sunscreen SPF 50
Class IICGMP Deviations
CA BOTANA International, Inc. · Oct 10, 2025
Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50
Class IICGMP Deviations
CA BOTANA International, Inc. · Oct 10, 2025
Showing 40 of 1,472 Class II recalls (1,769 tracked in total).
Related: which FDA-approved drugs are no longer marketed — our discontinued-drugs report →
What the recall classes mean
- Class I
- Most serious — a reasonable probability that use will cause serious harm or death.
- Class II
- May cause temporary or medically reversible harm; low probability of serious harm.
- Class III
- Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Data source: U.S. FDA openFDA Drug Enforcement Reports. This page reproduces FDA recall data for reference and is not medical advice. Always follow the FDA's and your pharmacist's guidance.