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
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only…
Class IICGMP Deviations; potential temperature excursions due to transit delays
Mckesson Medical-Surgical Inc. Corporate Office · Apr 21, 2025
Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL)
Class IIOut-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Eugia US LLC · Apr 21, 2025
Clindamycin Hydrochloride Capsules
Class IIcGMP Deviations
Preferred Pharmaceuticals, Inc. · Apr 18, 2025
niCARdipine Hydrochloride Injection
Class IILack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
American Regent, Inc. · Apr 18, 2025
niCARdipine Hydrochloride Injection
Class IILack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
American Regent, Inc. · Apr 18, 2025
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
Ropivacaine Hydrochloride Injection
Class IPresence of Particulate Matter
Amneal Pharmaceuticals, LLC · Apr 17, 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
HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL)
Class IIISuperpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
OurPharma 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
Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distribu…
Class IMarketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
SAINI TRADE INC · Apr 14, 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
MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distribu…
Class IMarketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
SAINI TRADE INC · Apr 14, 2025
Male Ultra Pro
Class IMarketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
SAINI TRADE INC · Apr 14, 2025
ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distrib…
Class IMarketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
SAINI TRADE INC · Apr 14, 2025
ELECTRO BUZZ
Class IMarketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
SAINI TRADE 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
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
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.