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
Inflectra (infliximab-dyyb)
Class IIcGMP Deviations: Product intended for quarantine was inadvertently distributed.
McKesson · Jan 17, 2025
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Jan 13, 2025
Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL
Class IIFailed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Teva Pharmaceuticals USA, Inc · Jan 10, 2025
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide…
Class IIFailed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Johnson, S C and Son, Inc · Jan 8, 2025
Clobazam Tablets
Class IIPresence of Foreign Tablets/Capsules
Amerisource Health Services LLC · Jan 7, 2025
Duloxetine Delayed-Release Capsules USP 20 mg
Class IICGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Rising Pharma Holding, Inc. · Dec 30, 2024
Metformin Hydrochloride Extended-Release Tablets
Class IIPresence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Granules Pharmaceuticals Inc. · Dec 30, 2024
Duloxetine DR Capsules USP 60 mg
Class IICGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Rising Pharma Holding, Inc. · Dec 30, 2024
Duloxetine Delayed-Release Capsules USP 30 mg
Class IICGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Rising Pharma Holding, Inc. · Dec 30, 2024
Progesterone Injection USP
Class IIPresence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Eugia US LLC · Dec 27, 2024
Cardura XL (doxazosin) extended release tablets 4 mg
Class IIFailed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Viatris Inc · Dec 23, 2024
Cardura XL (doxazosin) extended release tablets 8 mg
Class IIFailed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Viatris Inc · Dec 23, 2024
First Aid Beauty Ultra Repair Cream
Class IICGMP Deviations; product intended for quarantine was inadvertently distributed
First Aid Beauty Ltd · Dec 23, 2024
Levothyroxine Sodium Tablets
Class IIFailed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Lupin Pharmaceuticals Inc. · Dec 20, 2024
phenylephrine in 0.9% Sodium Chloride Inj
Class IILack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Hikma Injectables USA Inc · Dec 19, 2024
ketamine inj 50 mg per 1 mL
Class IILack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Hikma Injectables USA Inc · Dec 19, 2024
medroxyPROGESTERone Acetate Injectable Suspension
Class IICGMP Deviations
Eugia US LLC · 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
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
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
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
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.