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
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
Kroger 70% Isopropyl Alcohol
Class IIICross Contamination with Other Products.
Consumer Product Partners, LLC · Aug 25, 2025
TopCare Health 70% Isopropyl Alcohol
Class IIICross Contamination with Other Products.
Consumer Product Partners, LLC · 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
Carvedilol Tablets USP
Class IICGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Aug 20, 2025
Acetaminophen Injection 1000 mg/100 mL (10 mg/mL)
Class IIDiscoloration
Baxter Healthcare Corporation · Aug 20, 2025
Dextroamphetamine Saccharate
Class IIPresence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
Lannett Company Inc. · Aug 19, 2025
READYPREP PVP
Class IIISubpotent drug
Medline Industries, LP · Aug 19, 2025
Lactated Ringers's Injection USP
Class IPresence of Particulate Matter
B BRAUN MEDICAL INC · Aug 18, 2025
chlorproMAZINE Hydrochloride Tablets
Class IIPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Amneal Pharmaceuticals, LLC · Aug 18, 2025
Sulfamethoxazole and Trimethoprim Tablets
Class IIPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Amneal Pharmaceuticals, LLC · Aug 18, 2025
chlorproMAZINE Hydrochloride Tablets
Class IIPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Amneal Pharmaceuticals, LLC · Aug 18, 2025
chlorproMAZINE Hydrochloride Tablets
Class IIPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Amneal Pharmaceuticals, LLC · Aug 18, 2025
chlorproMAZINE Hydrochloride Tablets
Class IIPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Amneal Pharmaceuticals, LLC · Aug 18, 2025
0.9% Sodium Chloride Injection USP
Class IPresence of Particulate Matter.
B BRAUN MEDICAL INC · Aug 18, 2025
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only
Class IITemperature Abuse
Sandoz Inc · Aug 13, 2025
Tavaborole Topical Solution 5%
Class IIDiscoloration
VIONA PHARMACEUTICALS INC · Aug 12, 2025
Lisdexamfetamine Dimesylate Capsules
Class IILabeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Lannett Company Inc. · Aug 11, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Breckenridge Pharmaceutical, Inc. · Aug 8, 2025
Theophylline extended-release tablets 400mg
Class IIFailed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
Glenmark Pharmaceuticals Inc., USA · Aug 8, 2025
Carvedilol Tablets
Class IICGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Glenmark Pharmaceuticals Inc., USA · Aug 7, 2025
Carvedilol Tablets
Class IICGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Glenmark Pharmaceuticals Inc., USA · Aug 7, 2025
Carvedilol Tablets
Class IICGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Glenmark Pharmaceuticals Inc., USA · Aug 7, 2025
Metoprolol Tartrate Tablets
Class IICGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Westminster Pharmaceuticals LLC · Aug 6, 2025
Metoprolol Tartrate Tablets
Class IICGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Westminster Pharmaceuticals LLC · Aug 6, 2025
Carvedilol Tablets
Class IICGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Glenmark Pharmaceuticals Inc., USA · Aug 6, 2025
Carvedilol Tablets
Class IICGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Glenmark Pharmaceuticals Inc., USA · Aug 6, 2025
Spironolactone Tablets
Class IIPresence of foreign substance: identified as aluminum.
SUN PHARMACEUTICAL INDUSTRIES INC · Aug 5, 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.