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
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%…
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by…
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Rapidol Maximum Strength
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Artridon Glucosamine (menthol 2% and Methyl Salicylate 15%
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic…
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Maximum Security Anticavity Gel Toothpaste
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Maximum Security
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%…
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Nature Mint Anticavity Fluoride Toothpaste
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Nature Mint Anticavity Fluoride Toothpaste
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Class IIcGMP deviations and lack of assurance of sterility.
BRS Analytical Services, LLC · Apr 23, 2025
Lubricant Eye Drops Solution
Class IIcGMP deviations and lack of assurance of sterility.
BRS Analytical Services, LLC · Apr 23, 2025
Polyvinyl Alcohol Ophthalmic Solution 1.4%
Class IIcGMP deviations and lack of assurance of sterility.
BRS Analytical Services, LLC · Apr 23, 2025
Carboxymethylcellulose Sodium Ophthalmic Gel 1%
Class IIcGMP deviations and lack of assurance of sterility.
BRS Analytical Services, LLC · Apr 23, 2025
Artificial Tears Ophthalmic Solution
Class IIcGMP deviations and lack of assurance of sterility.
BRS Analytical Services, LLC · Apr 23, 2025
Clindamycin HCl Capsule
Class IICGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
RemedyRePack Inc. · Apr 22, 2025
PROLIA (denosumab)
Class IICGMP Deviations; potential temperature excursions due to transit delays
Mckesson Medical-Surgical Inc. Corporate Office · Apr 21, 2025
BENLYSTA (belimumab) for injection
Class IICGMP Deviations; potential temperature excursions due to transit delays
Mckesson Medical-Surgical Inc. Corporate Office · Apr 21, 2025
Tirofiban Hydrochloride Injection 5 mg/100 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
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use…
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
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…
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
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.