US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class I · High risk Terminated

ChloraPrep One-Step 2% w/v chlorhexidine gluconate

Reason Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.

CareFusion 213, LLC D-0345-2021
Class I · High risk Terminated

BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate

Reason Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.

CareFusion 213, LLC NDC 54365-400-33 D-0344-2021
Class I · High risk Terminated

BD ChloraPrep Clear

Reason Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.

CareFusion 213, LLC NDC 54365-400-32 D-0343-2021
Class II · Moderate risk Terminated

Neomycin Sulfate Tablets

Reason Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay

X-Gen Pharmaceuticals Inc. NDC 39822-0310-5 D-0328-2021
Class II · Moderate risk Terminated

Omeprazole Delayed Release Capsules

Reason Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer

Golden State Medical Supply Inc. NDC 51407-129-10 D-0312-2021
Class III · Low risk Terminated

Lcl-2-0191

Reason An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.

Washington Homeopathic Products, Inc. D-0323-2021
Class III · Low risk Terminated

Sp-4

Reason An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.

Washington Homeopathic Products, Inc. D-0322-2021
Class III · Low risk Terminated

Macula Pellets Homeopathic Medicine

Reason An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.

Washington Homeopathic Products, Inc. NDC 58770-190-42 D-0321-2021
Class I · High risk Terminated

Telmisartan Tablets

Reason Labeling: Label-mixup

Alembic Pharmaceuticals Limited NDC 62332-087-30 D-0326-2021
Class II · Moderate risk Terminated

Enalapril Maleate Tablets

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 64679-923-02 D-0597-2021
Class II · Moderate risk Terminated

Brompheniramine Maleate

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 60432-275-16 D-0596-2021
Class II · Moderate risk Terminated

CYANOCOBAL Injection 1000MCG/ML 25X1ML

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. D-0595-2021
Class II · Moderate risk Terminated

Corgard

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 27505-101-01 D-0594-2021
Class II · Moderate risk Terminated

HALOPERIDOL TABLETS 20mg

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. D-0593-2021
Class II · Moderate risk Terminated

Briviact

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 50474-570-66 D-0591-2021
Class II · Moderate risk Terminated

Vimpat

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 0131-2480-35 D-0590-2021
Class II · Moderate risk Terminated

Vimpat

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. D-0589-2021
Class II · Moderate risk Terminated

INTEGRA 325/40/3mg 90-count bottle

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. D-0588-2021
Class II · Moderate risk Terminated

Tramadol Hydrochloride Tablets USP 100mg

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. D-0586-2021
Class II · Moderate risk Terminated

Sulindac Tablets

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 42806-011-01 D-0582-2021