US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

Class II · Moderate risk Terminated

Union

Reason CGMP Deviations

H & H Remedies, LLC D-0071-2021
Class II · Moderate risk Terminated

Metformin HCL E/R 500 mg

Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Direct Rx NDC 72189-064-90 D-0058-2021
Class II · Moderate risk Terminated

Metformin Hydrochloride Extended Release 750 mg

Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

RemedyRepack Inc. NDC 70518-2480-00 D-0050-2021
Class II · Moderate risk Terminated

N-A-C

Reason Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.

Jarrow Formulas Inc D-0302-2021
Class II · Moderate risk Terminated

Salicylic Acid Shampoo 3%

Reason GMP Deviations

Milbar Laboratories, Inc. D-0096-2021
Class II · Moderate risk Terminated

DCL Alpha Beta Gel Toner

Reason GMP Deviations

Milbar Laboratories, Inc. D-0094-2021
Class II · Moderate risk Terminated

Willa Pore Perfector

Reason GMP Deviations

Milbar Laboratories, Inc. D-0093-2021
Class II · Moderate risk Terminated

Willa Clear Skin

Reason GMP Deviations

Milbar Laboratories, Inc. D-0092-2021
Class II · Moderate risk Terminated

DCL AHA Lightening Gel

Reason GMP Deviations

Milbar Laboratories, Inc. D-0085-2021
Class III · Low risk Terminated

Dextroamphetamine Saccharate

Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

ANI Pharmaceuticals, Inc. NDC 43975-282-10 D-0048-2021
Class III · Low risk Terminated

Dextroamphetamine Saccharate

Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

ANI Pharmaceuticals, Inc. NDC 43975-281-10 D-0047-2021
Class III · Low risk Terminated

Dextroamphetamine Saccharate

Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

ANI Pharmaceuticals, Inc. NDC 43975-280-10 D-0046-2021
Class III · Low risk Terminated

Dextroamphetamine Saccharate

Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

ANI Pharmaceuticals, Inc. NDC 43975-279-10 D-0045-2021
Class III · Low risk Terminated

Dextroamphetamine Saccharate

Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

ANI Pharmaceuticals, Inc. NDC 43975-278-10 D-0044-2021