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
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Glutathione 200 mg/mL
Class IMicrobial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
OPTIMAL BALANCE PHARMACY · Aug 5, 2026
Mirabegron Extended-Release Tablets
Class IICGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Zydus Pharmaceuticals (USA) Inc · Aug 5, 2026
Morphine Sulfate Injection
Class ILabeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Fresenius Kabi USA, LLC · Aug 4, 2026
Diovan (valsartan) 160 mg
Class IIFailed Dissolution Specifications
Novartis Pharmaceuticals Corporation · Aug 4, 2026
Carbamazepine Tablets
Class IICGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
SUN PHARMACEUTICAL INDUSTRIES INC · Aug 3, 2026
Clobetasol Propionate Cream USP
Class IIFailed content uniformity specifications.
Lupin Pharmaceuticals Inc. · Aug 3, 2026
TADALAFIL USP
Class IICGMP Deviations:Noted during FDA inspection
Shoolin Pharma Chem LLP · Aug 3, 2026
SILDENAFIL CITRATE USP
Class IICGMP Deviations:Noted during FDA inspection
Shoolin Pharma Chem LLP · Aug 3, 2026
TADALAFIL USP
Class IICGMP Deviations:Noted during FDA inspection
Shoolin Pharma Chem LLP · Aug 3, 2026
TADALAFIL USP
Class IICGMP Deviations:Noted during FDA inspection
Shoolin Pharma Chem LLP · Aug 3, 2026
SILDENAFIL CITRATE USP
Class IICGMP Deviations:Noted during FDA inspection
Shoolin Pharma Chem LLP · Aug 3, 2026
Optiray Imaging Bulk Package-350
Class IPresence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Liebel-Flarsheim Company LLC · Jul 31, 2026
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION
Class IIPresence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Heritage Pharmaceuticals Inc · Jul 30, 2026
PEMRYDI RTU(pemetrexed injection)
Class IIDiscolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Shilpa Medicare Limited · Jul 29, 2026
PEMRYDI RTU (pemetrexed injection)
Class IIDiscolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Shilpa Medicare Limited · Jul 29, 2026
SEMAGLUTIDE 5mg (1mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
SEMAGLUTIDE 4.5mg (0.9 mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
SEMAGLUTIDE 9mg (4.5 mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
SEMAGLUTIDE 10mg (5mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
SEMAGLUTIDE 20mg (5mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
CLEAR EYES Maximum Itchy Eye Relief
Class IILack of assurance of sterility. The recall is due to potential contamination
Prestige Brands Holdings · Jul 29, 2026
SEMAGLUTIDE 0.9mg (0.9 mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
SEMAGLUTIDE 6.75mg (4.5 mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
SEMAGLUTIDE 2.5mg (1mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
SEMAGLUTIDE 2.25MG (0.9 mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
SEMAGLUTIDE 12.5MG (2.5MG/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
SEMAGLUTIDE 7.5mg (5mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
Libtayo (cemiplimab-rwlc) Injection
Class IILack of Assurance of Sterility
Regeneron Pharmaceuticals Inc · Jul 28, 2026
Tralement (trace elements injection 4*
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
Cefazolin in Dextrose
Class IPresence of Particulate Matter
Baxter Healthcare Corporation · Jul 24, 2026
Cyanocobalamin injection USP
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
Selenious Acid Injection
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
AMINAOCAPROIC ACID INJECTION
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
niCARdipine Hydrochloride Injection
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
Acamprosate Calcium
Class IIFailed Dissolution Specifications
Mylan Pharmaceuticals Inc · Jul 24, 2026
Nitroglycerin injection
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
Atropine Sulfate injection
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
ACETYLCYSTEINE SOLUTION
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
Showing 40 of 1,895 recalls tracked.
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.