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: 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
Cinacalcet Tablets
Class IICGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
AvKARE · Nov 27, 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
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection
Class IILack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Curium US, LLC · Nov 26, 2024
Olanzapine Tablets
Class IIFailed Impurities/Degradation Specifications
Macleods Pharmaceuticals Ltd · Nov 25, 2024
VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt…
Class IICGMP deviations: out of specifications for assay
Apothecus Pharmaceutical Corp. · Nov 22, 2024
10 Irregular Pigmentation
Class IICGMP Deviations: Inconsistency in the water systems.
Generitech Corporation · Nov 22, 2024
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection
Class IIFailed Stability Specifications
Jubilant Draximage Inc., dba Jubilant Radiopharma · Nov 22, 2024
Dihydroergotamine Mesylate Injection
Class IIDiscoloration
Provepharm Inc. · Nov 22, 2024
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Rising Pharma Holding, Inc. · Nov 19, 2024
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Rising Pharma Holding, Inc. · Nov 19, 2024
Duloxetine DR Capsules USP 60 mg
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Rising Pharma Holding, Inc. · Nov 19, 2024
Levothyroxine Sodium Tablets
Class IISubpotent and Superpotent Drug
Mylan Institutional, Inc. · Nov 19, 2024
Levothyroxine Sodium Tablets
Class IISubpotent and Superpotent Drug
Mylan Institutional, Inc. · Nov 19, 2024
Levothyroxine Sodium Tablets
Class IISubpotent and Superpotent Drug
Mylan Institutional, Inc. · Nov 19, 2024
Levothyroxine Sodium Tablets
Class IISubpotent and Superpotent Drug
Mylan Institutional, Inc. · Nov 19, 2024
Levothyroxine Sodium Tablets
Class IISubpotent and Superpotent Drug
Mylan Institutional, Inc. · Nov 19, 2024
Levothyroxine Sodium Tablets
Class IISubpotent and Superpotent Drug
Mylan Institutional, Inc. · Nov 19, 2024
Levothyroxine Sodium Tablets USP
Class IISuperpotent Drug and Subpotent Drug: potency failures obtained
Viatris Inc · Nov 18, 2024
Levothyroxine Sodium Tablets USP
Class IISuperpotent Drug and Subpotent Drug: potency failures obtained
Viatris Inc · Nov 18, 2024
Levothyroxine Sodium Tablets USP
Class IISuperpotent Drug and Subpotent Drug: potency failures obtained
Viatris Inc · Nov 18, 2024
Levothyroxine Sodium Tablets USP
Class IISuperpotent Drug and Subpotent Drug: potency failures obtained
Viatris Inc · Nov 18, 2024
Levothyroxine Sodium Tablets USP
Class IISuperpotent Drug and Subpotent Drug: potency failures obtained
Viatris Inc · Nov 18, 2024
Levothyroxine Sodium Tablets USP
Class IISuperpotent Drug and Subpotent Drug: potency failures obtained
Viatris Inc · Nov 18, 2024
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.