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
Succinylcholine Chloride Injection
Class IIOut-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Dr. Reddy's Laboratories, Inc. · Sep 26, 2025
Aloe Up Sport Performance Sunscreen Lotion SPF 30
Class IIcGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
SV Labs Prescott Corporation · Sep 25, 2025
Entecavir Tablets
Class IIFailed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Zydus Pharmaceuticals (USA) Inc · Sep 24, 2025
Entecavir Tablets
Class IIFailed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Zydus Pharmaceuticals (USA) Inc · Sep 24, 2025
Fentanyl citrate
Class IICGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Park Avenue Compounding · Sep 23, 2025
Sting Relief Swabs
Class IIProduct Mix-up
ACME UNITED CORPORATION · Sep 23, 2025
Bevacizumab 1.75 mg/0.07 mL
Class IILack of assurance of sterility.
RC Outsourcing, LLC · Sep 22, 2025
Atorvastatin Calcium Tablets USP
Class IIFailed Dissolution Specifications
Ascend Laboratories, LLC · Sep 19, 2025
Atorvastatin Calcium Tablets USP
Class IIFailed Dissolution Specifications
Ascend Laboratories, LLC · Sep 19, 2025
Atorvastatin Calcium Tablets USP
Class IIFailed Dissolution Specifications
Ascend Laboratories, LLC · Sep 19, 2025
Atorvastatin Calcium Tablets USP
Class IIFailed Dissolution Specifications
Ascend Laboratories, LLC · Sep 19, 2025
Phenylephrine HCI
Class IICGMP Deviations
Park Avenue Compounding · Sep 17, 2025
Azelaic Acid Gel
Class IICGMP Deviations: Market complaints received for gritty texture (grainy)
Glenmark Pharmaceuticals Inc., USA · Sep 17, 2025
Levothyroxine Sodium Tablets
Class IISubpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
ACCORD HEALTHCARE, INC. · Sep 16, 2025
Carbamazepine Extended-Release Tablets
Class IIFailed Dissolution Specifications.
Amerisource Health Services LLC · Sep 15, 2025
Bupropion Hydrochloride Extended-Release Tablets USP (XL)
Class IIFailed Tablet/Capsule Specifications
Graviti Pharmaceuticals Private Limited · Sep 15, 2025
Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Pero…
Class IIChemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Private Label Skin Care Inc. · Sep 12, 2025
Skin MD by Dr Monika Kiripolsky
Class IIChemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Private Label Skin Care Inc. · Sep 12, 2025
Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD
Class IIChemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Private Label Skin Care Inc. · Sep 12, 2025
Major ChlorproMAZINE Hydrochloride Tablets
Class IICGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Sep 12, 2025
mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Skin…
Class IIChemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Private Label Skin Care Inc. · Sep 12, 2025
Major ChlorproMAZINE Hydrochloride Tablets
Class IICGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Sep 12, 2025
Major ChlorproMAZINE Hydrochloride Tablets
Class IICGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Sep 12, 2025
Major ChlorproMAZINE Hydrochloride Tablets
Class IICGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Sep 12, 2025
Major ChlorproMAZINE Hydrochloride Tablets
Class IICGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Sep 12, 2025
ARTISAN OF SKIN (Benzoyl Peroxide 10%)
Class IIChemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Private Label Skin Care Inc. · Sep 12, 2025
edunn clarity
Class IIChemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Private Label Skin Care Inc. · Sep 12, 2025
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL)
Class IIcGMP deviations: Temperature excursion during transportation.
Sandoz Inc · Sep 5, 2025
Ketorolac Tromethamine Ophthalmic Solution
Class IILack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Apotex Corp. · Sep 5, 2025
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Class IILack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Apotex Corp. · Sep 5, 2025
Entecavir Tablets
Class IIFailed Impurity/Degradation Specifications
Zydus Pharmaceuticals (USA) Inc · Sep 4, 2025
Entecavir Tablets
Class IIFailed Impurity/Degradation Specifications
Zydus Pharmaceuticals (USA) Inc · Sep 4, 2025
Chlorpromazine Hydrochloride Tablets
Class IICGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc · Sep 3, 2025
Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Es…
Class IIFailed Impurities/Degradation Specifications
Glenmark Pharmaceuticals Inc., USA · Sep 3, 2025
Chlorpromazine Hydrochloride Tablets
Class IICGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc · Sep 3, 2025
Chlorpromazine Hydrochloride Tablets
Class IICGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc · Sep 3, 2025
Kit for the Preparation of Technetium Tc 99m Mertiatide
Class IIFailed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
SUN PHARMACEUTICAL INDUSTRIES INC · Sep 3, 2025
Chlorpromazine Hydrochloride Tablets
Class IICGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc · Sep 3, 2025
Chlorpromazine Hydrochloride Tablets
Class IICGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc · Sep 3, 2025
Chlorpromazine Hydrochloride Tablets
Class IICGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc · Sep 3, 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.