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
EPINEPHRINE Injection
Class IILack of Assurance of Sterility
International Medication Systems Ltd. · Apr 1, 2026
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride
Class IIcGMP deviations.
Wells Pharma of Houston LLC · Apr 1, 2026
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
Class IIcGMP deviations.
Wells Pharma of Houston LLC · Apr 1, 2026
Ketamine Hydrochloride Injectable Solution
Class IIcGMP deviations.
Wells Pharma of Houston LLC · Apr 1, 2026
Prazosin Hydrochloride Capsules
Class IIcGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Appco Pharma LLC · Mar 27, 2026
Prazosin Hydrochloride Capsules
Class IIcGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Appco Pharma LLC · Mar 27, 2026
Prazosin Hydrochloride Capsules
Class IIcGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Appco Pharma LLC · Mar 27, 2026
Pantoprazole Sodium
Class IIDiscoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Hetero Labs Limited (Unit V) · Mar 26, 2026
Artificial Tears Lubricant Eye Drops (glycerin 0.2%
Class IILack of Assurance of Sterility
Preferred Pharmaceuticals, Inc. · Mar 25, 2026
Fluocinonide
Class IIFailed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
SUN PHARMACEUTICAL INDUSTRIES INC · Mar 25, 2026
Fluocinonide
Class IIFailed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
SUN PHARMACEUTICAL INDUSTRIES INC · Mar 25, 2026
Fluocinonide
Class IIFailed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
SUN PHARMACEUTICAL INDUSTRIES INC · Mar 25, 2026
GE Healthcare Omnipaque (iohexol) Injection
Class IIPresence of particulate matter
GE Healthcare Ireland Limited · Mar 24, 2026
Memantine Hydrochloride Extended-Release
Class IIFailed Dissolution Specifications
The Harvard Drug Group LLC · Mar 24, 2026
GE Healthcare Omnipaque (iohexol) Injection
Class IIPresence of particulate matter
GE Healthcare Ireland Limited · Mar 24, 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
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Drops, Honey Lemon…
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 HCL
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
norepinephrine Bitartrate
Class IILack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Fagron Compounding Services · Mar 20, 2026
caring mill, Menthol Cough Suppressant Oral Anesthetic, Drops, Cherry, 90-count…
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
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
norepinephrine Bitartrate
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
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, 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, Drops, Honey Lemon…
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
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.