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
Clindamycin Injection USP in 5% Dextrose
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4…
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Vancomycin Injection
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Famotidine Injection in Sodium Chloride
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1…
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Clindamycin Injection USP in 5% Dextrose
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Clindamycin Injection USP in 5% Dextrose
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Nexterone (amiodarone HCI)
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), mg…
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Pantoprazole Sodium in 0.9% Chloride Injection
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL)…
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2…
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Clindamycin Injection USP in 5% Dextrose
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Acthar Gel (repository corticotropin injection)
Class IIPresence of particulate matter: glass and stopper piece
Mallinckrodt Hospital Products Inc. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 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
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
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
Showing 40 of 1,576 Class II recalls (1,895 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.