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 Irrigation USP
Class IIPresence of Particulate Matter
B. Braun Medical Inc · Mar 31, 2025
dexmedeTOMIDine HCl PF
Class IILack of Assurance of Sterility: Leaking/damaged syringes.
Denver Solutions, LLC DBA Leiters Health · Mar 31, 2025
Bimatoprost powder
Class IICGMP Deviations
Medisca Inc. · Mar 31, 2025
Rocuronium Bromide 50 mg per 5mL (10mg per mL)
Class IILack of Assurance of Sterility: Leaking/damaged syringes.
Denver Solutions, LLC DBA Leiters Health · Mar 31, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Breckenridge Pharmaceutical, Inc. · Mar 26, 2025
Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules…
Class IICGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
Chattem Inc · Mar 26, 2025
Clindamycin HCl
Class IICGMP Deviations
RemedyRepack Inc. · Mar 24, 2025
Voriconazole Tablets
Class IIcGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Amerisource Health Services LLC · Mar 24, 2025
Haloperidol Decanoate Injection 100mg/mL
Class IILack of Assurance of Sterility: Media fill with bacterial contamination
Somerset Therapeutics Private Limited · Mar 21, 2025
Haloperidol Decanoate Injection 50mg/mL
Class IILack of Assurance of Sterility: Media fill with bacterial contamination
Somerset Therapeutics Private Limited · Mar 21, 2025
Haloperidol Decanoate Injection
Class IILack of Assurance of Sterility: Media fill with bacterial contamination
Somerset Therapeutics Private Limited · Mar 21, 2025
Methocarbamol Injection USP 1
Class IILack of Assurance of Sterility: Media fill with bacterial contamination
Somerset Therapeutics Private Limited · Mar 21, 2025
Venlafaxine Tablets
Class IIPresence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Zydus Pharmaceuticals (USA) Inc · Mar 21, 2025
Haloperidol Decanoate Injection 50mg/mL
Class IILack of Assurance of Sterility: Media fill with bacterial contamination
Somerset Therapeutics Private Limited · Mar 21, 2025
Atorvastatin Calcium Tablets USP 40 mg
Class IIFailed dissolution specifications: lower than specifications
BIOCON PHARMA INC · Mar 17, 2025
Fluphenazine Hydrochloride Tablets 2.5mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Teriflunomide Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Solifenacin Succinate Tablets 10MG
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Voriconazole Tablets 200 mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Propafenone Hydrochloride Extended-Release Capsules 225mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Lacosamide Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Nitroglycerin Sublingual Tablets 0.3MG
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Clindamycin Hydrochloride Capsules
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Indomethacin Extended-Release Capsules
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Rosuvastatin Tablets 40mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Propafenone Hydrochloride Extended-Release Capsules
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Fluphenazine Hydrochloride Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Lacosamide Tablets 200mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Pravastatin Sodium Tablets 80mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Rufinamide Tablets 200mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Propafenone Hydrochloride Extended-Release Capsules USP
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Carvedilol Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Pravastatin Sodium Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Lacosamide Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Acetaminophen and Ibuprofen (NSAID) Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Saxagliptin Tablets 5mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Colesvelam Hydrocholoride Tablets 625mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Voriconazole Tablets 50mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Showing 40 of 1,769 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.