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
Methadone Hydrochloride Tablets
Class IIIFailed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
West-Ward Columbus Inc · Dec 19, 2024
Polyvinyl Alcohol Ophthalmic Solution 1.4%
Class IIILABELING: LABEL MIX-UP
AvKARE · Dec 18, 2024
medroxyPROGESTERone Acetate Injectable Suspension
Class IICGMP Deviations
Eugia US LLC · Dec 18, 2024
Systane Lubricant Eye Drops
Class INon-Sterility
Alcon Research LLC · Dec 18, 2024
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant…
Class IIILABELING: LABEL MIX-UP
AvKARE · Dec 18, 2024
Colchicine Capsules 0.6 mg
Class IIFailed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Granules Pharmaceuticals Inc. · Dec 18, 2024
glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards)…
Class IIFailed Dissolution Specifications:
Amerisource Health Services LLC · Dec 17, 2024
Atropine Sulfate Ophthalmic Solution
Class IIIFailed Impurities/Degradation Specifications
SOMERSET THERAPEUTICS LLC · Dec 16, 2024
FOUZEE SugarLin HERBAL FORMULA capsules
Class IMarketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
SHOPPERS- PLAZA · Dec 16, 2024
Ciprofloxacin Ophthalmic Solution USP
Class IIDefective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
FDC Limited · Dec 16, 2024
Clobazam Tablets
Class IIPresence of Foreign Tablets/Capsules
Amerisource Health Services LLC · Dec 13, 2024
FORCE FOREVER 400mg Tablets
Class IMarketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
GNMart LLC · Dec 12, 2024
Acetaminophen Extra Strength 500 mg
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
Acetaminophen Extra Strength 500 mg
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
Diphenhydramine HCl 25 mg
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
Acetaminophen Regular Strength
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
Dabigatran Etexilate
Class IICGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Ascend Laboratories, LLC · Dec 12, 2024
Dabigatran Etexilate
Class IICGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Ascend Laboratories, LLC · Dec 12, 2024
Nhan Sam Tuyet Lien Truy Phong Hoan
Class IMarketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
Buy-Herbal · Dec 12, 2024
Diphenhydramine HCl 50 mg
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
Diphenhydramine HCl 25 mg
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
Acetaminophen
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
chlorproMAZINE Hydrochloride Tablets
Class IICGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Dec 11, 2024
chlorproMAZINE Hydrochloride Tablets
Class IICGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Dec 11, 2024
Dapsone Gel 7.5%
Class IICrystallization
VIONA PHARMACEUTICALS INC · Dec 10, 2024
PROFESSIONAL Regener-Eyes
Class IILack of Sterility Assurance
Regenerative Processing Plant, LLC · Dec 10, 2024
LITE Regener-Eyes
Class IILack of Sterility Assurance
Regenerative Processing Plant, LLC · Dec 10, 2024
Dapsone Gel 7.5%
Class IICrystallization
VIONA PHARMACEUTICALS INC · Dec 10, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Amerisource Health Services LLC · Dec 6, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical, Inc · Dec 6, 2024
Nebivolol Tablets
Class IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Aurobindo Pharma USA Inc · Dec 6, 2024
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Amerisource Health Services LLC · Dec 6, 2024
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Amerisource Health Services LLC · Dec 6, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Amerisource Health Services LLC · Dec 6, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical, Inc · Dec 6, 2024
Timolol Maleate Ophthalmic Solution USP
Class IIDefective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
FDC Limited · Dec 5, 2024
DULoxetine DR USP
Class IICGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
PD-Rx Pharmaceuticals, Inc. · Dec 4, 2024
Nitrofurantoin Capsules
Class IIFailed Dissolution Specifications
AvKARE · Dec 4, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
RemedyRepack Inc. · Dec 2, 2024
Cinacalcet Tablets
Class IICGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
AvKARE · Nov 27, 2024
Showing 40 of 1,903 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.