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
AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: A…
Class IIcGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Acuity Specialty Products, Inc. · Sep 29, 2025
Doxycycline Hyclate Tablets
Class IIFailed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Acella Pharmaceuticals, LLC · Sep 29, 2025
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
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use
Class ISubpotent Drug: Testing revealed there was no oxytocin in the IV bag.
IntegraDose Compounding Services LLC · 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
Cetirizine Hydrochloride Tablets USP 10 mg
Class IIITablet/Capsules Imprinted with Wrong ID
JB Chemicals and Pharmaceuticals Ltd · 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
Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
Class IIILabeling: Not Elsewhere Classified
Letco Medical LLC · Sep 12, 2025
Cetirizine Hydrochloride Tablets USP 10 mg
Class IIITablet/Capsules Imprinted with Wrong ID
JB Chemicals and Pharmaceuticals Ltd · 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
Everolimus tablets 5mg
Class IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo USA, Inc. · Sep 5, 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
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.