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
Timolol Maleate Ophthalmic Solution USP
Class IIDefective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
FDC Limited · Apr 18, 2025
Rapidol Arnica Tablets
Class IIcGMP deviations
Pharmadel, LLC · Apr 15, 2025
FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL
Class IILack of Assurance of Sterility
Apollo Care, LLC · Apr 15, 2025
DoloEar Earache Drops
Class IIcGMP deviations
Pharmadel, LLC · Apr 15, 2025
Rapidol Arnica Gel
Class IIcGMP deviations
Pharmadel, LLC · Apr 15, 2025
Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl (15…
Class IIcGMP deviations
Pharmadel, LLC · Apr 15, 2025
Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL)
Class IILabeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
Nubratori, Inc · Apr 15, 2025
DoloDent Maximum Strength Toothache Drops
Class IIcGMP deviations
Pharmadel, LLC · Apr 15, 2025
Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablet…
Class IIcGMP deviations
Pharmadel, LLC · Apr 15, 2025
ChlorproMAZINE Hydrochloride Tablets
Class IICGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Apr 14, 2025
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Breckenridge Pharmaceutical, Inc · Apr 14, 2025
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Breckenridge Pharmaceutical, Inc · Apr 14, 2025
Levothyroxine Sodium Tablets
Class IISubpotent
ACCORD HEALTHCARE, INC. · Apr 10, 2025
Levothyroxine Sodium Tablets
Class IISubpotent
ACCORD HEALTHCARE, INC. · Apr 10, 2025
clomiPRAMINE hydrochloride Capsules USP
Class IIFailed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Lupin Pharmaceuticals Inc. · Apr 10, 2025
Levothyroxine Sodium Tablets
Class IISubpotent
ACCORD HEALTHCARE, INC. · Apr 10, 2025
Testosterone Cypionate Injection
Class IIcGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Eugia US LLC · Apr 10, 2025
Levothyroxine Sodium Tablets
Class IISubpotent
ACCORD HEALTHCARE, INC. · Apr 10, 2025
Kapsin Ointment
Class IICGMP Deviations
Apipharma · Apr 9, 2025
Wegovy (semaglutide) injection
Class IITemperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.
Cardinal Health Inc. · Apr 9, 2025
Hemopropin Ointment
Class IICGMP Deviations
Apipharma · Apr 9, 2025
chlorproMAZINE Hydrochloride Tablets
Class IICGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Zydus Pharmaceuticals (USA) Inc · Apr 3, 2025
Haloperidol Decanoate Injection
Class IILack of assurance of sterility. Bacterial contamination detected in some media fill units
Amerisource Health Services LLC · Apr 2, 2025
Haloperidol Decanoate Injection
Class IILack of assurance of sterility. Bacterial contamination detected in some media fill units
Amerisource Health Services LLC · Apr 2, 2025
Haloperidol Decanoate Injection
Class IILack of assurance of sterility. Bacterial contamination detected in some media fill units
Amerisource Health Services LLC · Apr 2, 2025
PHENYLephrine HCl in 0.9% Sodium Chloride
Class IILack of Assurance of Sterility: Leaking/damaged syringes.
Denver Solutions, LLC DBA Leiters Health · Mar 31, 2025
Ketamine HCl 50mg per 5mL (10 mg per mL)
Class IILack of Assurance of Sterility: Leaking/damaged syringes.
Denver Solutions, LLC DBA Leiters Health · Mar 31, 2025
Glycopyrrolate
Class IILack of Assurance of Sterility: Leaking/damaged syringes.
Denver Solutions, LLC DBA Leiters Health · Mar 31, 2025
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
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.