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
QC Quality Choice
Class IIThis recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Mar 20, 2026
QC Quality Choice
Class IIThis recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Mar 20, 2026
QC Quality Choice
Class IIThis recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Mar 20, 2026
Discount Drug Mart Food Market
Class IIThis recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Mar 20, 2026
Vancomycin HCI
Class IILack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Fagron Compounding Services · Mar 20, 2026
QC Quality Choice
Class IIThis recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Mar 20, 2026
Furosemide Tablets
Class IICGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Leading Pharma, LLC · Mar 20, 2026
exchange select
Class IIThis recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Mar 20, 2026
Discount Drug Mart Food Market
Class IIThis recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Mar 20, 2026
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free…
Class IIThis recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Mar 20, 2026
Vancomycin HCI
Class IILack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Fagron Compounding Services · Mar 20, 2026
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemo…
Class IIThis recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Mar 20, 2026
Clonidine Transdermal System
Class IICGMP Deviations: use of an unapproved raw material
Teva Pharmaceuticals USA, Inc · Mar 19, 2026
Clonidine Transdermal System
Class IICGMP Deviations: use of an unapproved raw material
Teva Pharmaceuticals USA, Inc · Mar 19, 2026
Clonidine Transdermal System
Class IICGMP Deviations: use of an unapproved raw material
Teva Pharmaceuticals USA, Inc · Mar 19, 2026
traMADol Hydrochloride Tablets
Class IIFailed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
Amneal Pharmaceuticals, LLC · Mar 19, 2026
CUROSURF (poractant alfa)
Class IILack of Assurance of Sterility
Chiesi USA, Inc. · Mar 17, 2026
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx onl…
Class IIFailed Dissolution Specifications
Viatris, Inc. · Mar 17, 2026
Octreotide Acetate for Injectable Suspension
Class IILack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Teva Pharmaceuticals USA, Inc · Mar 17, 2026
Albuterol Sulfate Inhalation Solution
Class IILabelling: Illegible label
Nephron SC, LLC · Mar 17, 2026
Octreotide Acetate for Injectable Suspension
Class IILack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Teva Pharmaceuticals USA, Inc · Mar 17, 2026
Octreotide Acetate for Injectable Suspension
Class IILack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Teva Pharmaceuticals USA, Inc · Mar 17, 2026
Cinacalcet Hydrochloride Tablets
Class IICGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Cipla USA, Inc. · Mar 16, 2026
Meclizine Hydrochloride Tablets
Class IIFailed tablet specifications.
Amerisource Health Services LLC · Mar 16, 2026
Cinacalcet Hydrochloride Tablets
Class IICGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Cipla USA, Inc. · Mar 16, 2026
Cinacalcet Hydrochloride Tablets
Class IICGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Cipla USA, Inc. · Mar 16, 2026
Lanreotide Injection
Class IILack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Cipla USA, Inc. · Mar 13, 2026
Buprenorphine Hydrochloride
Class IICrystallization; identified as Buprenorphine free base
ENDO USA, Inc. · Mar 13, 2026
Lanreotide Injection
Class IILack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Cipla USA, Inc. · Mar 13, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
5% Dextrose Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
5% Dextrose Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
5% Dextrose Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
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.