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
Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl…
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 Rx…
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 Tablets, 0.01…
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
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
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
Sulfamethoxazole and Trimethoprim
Class IIPresence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Sep 2, 2025
Sulfamethoxazole and Trimethoprim
Class IIPresence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Sep 2, 2025
Norgestimate and Ethinyl Estradiol Tablets
Class IIFailed Content Uniformity Specifications
AvKARE · Sep 2, 2025
bevacizumab (Avastin) Injection
Class IILack of Assurance of Sterility
Fagron Compounding Services · Aug 29, 2025
Aripiprazole Tablets
Class IISuperpotent drug
Ascend Laboratories, LLC · Aug 28, 2025
DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a)…
Class IICGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
DermaRite Industries, LLC · Aug 27, 2025
4-N-1 Skin Protectant
Class IICGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
DermaRite Industries, LLC · Aug 27, 2025
McKesson Skin Protectant
Class IICGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
DermaRite Industries, LLC · Aug 27, 2025
Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz)…
Class IICGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
DermaRite Industries, LLC · Aug 27, 2025
Renew Skin Repair Cream
Class IICGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
DermaRite Industries, LLC · Aug 27, 2025
chlorproMAZINE Hydrochloride Tablets
Class IIPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Amerisource Health Services LLC · Aug 27, 2025
Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC…
Class IICGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
DermaRite Industries, LLC · Aug 27, 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.