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
Sterile Water for Injection USP
Class IILack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
B BRAUN MEDICAL INC · Apr 2, 2026
Lidocaine HCl injection
Class IILack of Assurance of Sterility
Huons Co., Ltd. · Apr 2, 2026
0.9 % SODIUM CHLORIDE IRRIGATION
Class IILack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
B BRAUN MEDICAL INC · Apr 2, 2026
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection
Class IILack of Assurance of Sterility
Huons Co., Ltd. · Apr 2, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Huons Co., Ltd. · Apr 2, 2026
LACTATED RINGER'S IRRIGATION
Class IILack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
B BRAUN MEDICAL INC · Apr 2, 2026
DEXTROSE INJECTION USP
Class IILack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
B BRAUN MEDICAL INC · Apr 2, 2026
Blemish Spot Treatment (Salicylic Acid) 1%
Class IIFailed Stability Specifications
Island Kinetics, Inc. d.b.a. CoValence Laboratories · Apr 1, 2026
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
Class IIcGMP deviations.
Wells Pharma of Houston LLC · Apr 1, 2026
Phenylephrine Hydrochloride Injectable Solution
Class IIcGMP deviations.
Wells Pharma of Houston LLC · Apr 1, 2026
fentaNYL Citrate Injectable Solution
Class IIcGMP deviations.
Wells Pharma of Houston LLC · Apr 1, 2026
fentaNYL Citrate Injectable Solution
Class IIcGMP deviations.
Wells Pharma of Houston LLC · Apr 1, 2026
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
Magnesium Chloride
Class IIISubpotent drug
Avantor Performance Materials LLC · Mar 31, 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, 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
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, Cough Drops, Cherry, 90-…
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
Showing 40 of 1,769 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.