US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

Olmesartan Medoxomil Tablets 20 mg

Reason cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.

Ascend Laboratories LLC NDC 67877-446-90 D-0828-2020
Class III · Low risk Terminated

Minocycline Hydrochloride Extended-Release Tablets

Reason Failed Dissolution Specifications: low out of specification results for dissolution testing.

Ascend Laboratories LLC NDC 67877-438-30 D-0827-2020
Class III · Low risk Terminated

Montelukast Sodium Chewable Tablets

Reason Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product

Macleods Pharma Usa Inc NDC 33342-111-10 D-0823-2020
Class II · Moderate risk Terminated

Walgreens Acne Cleansing Bar

Reason Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing).

Shandex Personal Care Manufacturing Inc. D-0822-2020
Class II · Moderate risk Terminated

Zinc Chloride Injection

Reason Lack of Assurance of Sterility

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0224-3 D-0994-2020
Class II · Moderate risk Terminated

Cholecalciferol

Reason Lack of Assurance of Sterility

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0251-3 D-0993-2020
Class II · Moderate risk Terminated

Cholecalciferol

Reason Lack of Assurance of Sterility

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0210-3 D-0992-2020
Class II · Moderate risk Terminated

Triamcinolone Acetonide

Reason Lack of Assurance of Sterility

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0633-1 D-0988-2020
Class II · Moderate risk Terminated

Triamcinolone Acetonide

Reason Lack of Assurance of Sterility

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0635-2 D-0987-2020
Class II · Moderate risk Terminated

Testosterone Cypionate Injection

Reason Lack of Assurance of Sterility

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0530-2 D-0984-2020
Class II · Moderate risk Terminated

Testosterone Cypionate Injection

Reason Lack of Assurance of Sterility

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0530-1 D-0983-2020
Class II · Moderate risk Terminated

Super MIC Injection

Reason Lack of Assurance of Sterility

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0234-3 D-0982-2020
Class II · Moderate risk Terminated

Selenium Injection

Reason Lack of Assurance of Sterility

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0227-3 D-0981-2020
Class II · Moderate risk Terminated

Pyridoxine Hydrochloride Injection

Reason Lack of Assurance of Sterility

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0216-3 D-0980-2020
Class II · Moderate risk Terminated

Iohexol

Reason Lack of Assurance of Sterility

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-1413-5 D-0979-2020
Class II · Moderate risk Terminated

Nicotinamide Adenine Dinucleotide

Reason Lack of Assurance of Sterility

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0336-1 D-0978-2020
Class II · Moderate risk Terminated

Nicotinamide Adenine Dinucleotide

Reason Lack of Assurance of Sterility

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0306-1 D-0977-2020
Class II · Moderate risk Terminated

Mitomycin-C

Reason Lack of Assurance of Sterility

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0812-8 D-0976-2020
Class II · Moderate risk Terminated

MIC-PLUS Injection

Reason Lack of Assurance of Sterility

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0231-3 D-0975-2020
Class II · Moderate risk Terminated

MIC-PLEX Injection

Reason Lack of Assurance of Sterility

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0233-3 D-0974-2020