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
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) (ND…
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 61924-102-08…
Class IICGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
DermaRite Industries, LLC · Aug 27, 2025
GelRite Instant Hand Sanitizer
Class IICGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
DermaRite Industries, LLC · Aug 27, 2025
Succinylcholine Chloride Injection
Class IIFailed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Zydus Pharmaceuticals (USA) Inc · Aug 27, 2025
UltraSure Anti-Perspirant & Deodorant
Class IICGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
DermaRite Industries, LLC · Aug 27, 2025
San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industrie…
Class IICGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
DermaRite Industries, LLC · Aug 27, 2025
Neuroquell & Neuroquell Plus
Class IIcGMP violations
Atlantic Management Resources Ltd. · Aug 27, 2025
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2…
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
Renew PeriProtect
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
PeriGuard Ointment
Class IICGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
DermaRite Industries, LLC · Aug 27, 2025
DermaMed Ointment
Class IICGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
DermaRite Industries, LLC · Aug 27, 2025
PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottl…
Class IICGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
DermaRite Industries, LLC · Aug 27, 2025
DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, D…
Class IICGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
DermaRite Industries, LLC · Aug 27, 2025
DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.…
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
KleenFoam Antimicrobial Foam Soap
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, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (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
STERILE WATER FOR INJECTION USP
Class IILack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
B BRAUN MEDICAL INC · Aug 26, 2025
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION
Class IILack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
B BRAUN MEDICAL INC · Aug 26, 2025
chloroproMAZINE Hydrochloride Tablets
Class IIPresence of a foreign substance.
AvKARE · Aug 25, 2025
chloroproMAZINE Hydrochloride Tablets
Class IIPresence of a foreign substance.
AvKARE · Aug 25, 2025
Ultra Violette
Class IISubpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
GRACE & FIRE PTY LTD · Aug 22, 2025
Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Minera…
Class IISubpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
GRACE & FIRE PTY LTD · Aug 22, 2025
Sulfamethoxazole and Trimethoprim Tablets
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.
Northwind Pharmaceuticals LLC · Aug 20, 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.