US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

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

metformin HCL ER 500 mg

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

PD-Rx Pharmaceuticals, Inc. D-0059-2021
Class II · Moderate risk Terminated

Catapres

Reason An extraneous peak was observed for dissolution testing.

Boehringer Ingelheim Pharmaceuticals, Inc. D-0053-2021
Class II · Moderate risk Terminated

Catapres

Reason An extraneous peak was observed for dissolution testing.

Boehringer Ingelheim Pharmaceuticals, Inc. D-0052-2021
Class II · Moderate risk Terminated

Catapres

Reason An extraneous peak was observed for dissolution testing.

Boehringer Ingelheim Pharmaceuticals, Inc. D-0051-2021
Class II · Moderate risk Terminated

Time-Cap Labs

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

Marksans Pharma Limited NDC 49483-624-01 D-0062-2021
Class II · Moderate risk Terminated

Time-Cap Labs

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

Marksans Pharma Limited NDC 49483-623-09 D-0061-2021
Class II · Moderate risk Terminated

Riomet ER

Reason CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.

Sun Pharmaceutical Industries INC NDC 10631-019-17 D-0002-2021
Class II · Moderate risk Terminated

Nature-Throid 1 GR

Reason CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.

PD-Rx Pharmaceuticals, Inc. NDC 43063-819-01 D-0005-2021
Class II · Moderate risk Terminated

Albuterol Sulfate Inhalation Aerosol

Reason Defective Delivery System: Sustained trend of failure to dispense complaints.

Perrigo Company PLC NDC 45802-088-01 D-1594-2020
Class II · Moderate risk Terminated

Phentermine

Reason cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.

Calvin Scott & Company, Inc. NDC 00527-0597-10 D-0011-2021
Class II · Moderate risk Terminated

Diethylpropion

Reason cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.

Calvin Scott & Company, Inc. NDC 00527-1477-01 D-0010-2021
Class II · Moderate risk Terminated

Diethylpropion

Reason cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.

Calvin Scott & Company, Inc. NDC 00527-1475-01 D-0009-2021
Class II · Moderate risk Terminated

Buprenorphine Transdermal System 5 mcg/hour

Reason Failed Stability Specifications: Below specification result for buprenorphine release rate.

Teva Pharmaceuticals USA D-0003-2021
Class II · Moderate risk Terminated

Eye Itch Relief

Reason CGMP Deviations

Akorn, Inc. NDC 59779-920-01 D-1628-2020
Class II · Moderate risk Terminated

bio aaa Alcohol en Gel Antibacterial

Reason CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.

Ajr Trading LLC D-1620-2020
Class II · Moderate risk Terminated

Nature-Throid

Reason CGMP Deviations

Preferred Pharmaceuticals, Inc. NDC 68788-7605-09 D-1624-2020
Class II · Moderate risk Terminated

Nature-Throid

Reason CGMP Deviations

Preferred Pharmaceuticals, Inc. NDC 68788-7604-09 D-1623-2020
Class II · Moderate risk Terminated

Nature-Throid

Reason CGMP Deviations

Preferred Pharmaceuticals, Inc. NDC 68788-6860-09 D-1622-2020
Class II · Moderate risk Terminated

Nature-Throid

Reason CGMP Deviations

Preferred Pharmaceuticals, Inc. NDC 68788-9283-01 D-1621-2020
Class II · Moderate risk Terminated

Hand Sanitizer

Reason CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits.

Charles Paint Research Inc D-0792-2021
Class II · Moderate risk Terminated

Hand Sanitizer

Reason CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.

Charles Paint Research Inc D-0791-2021
Class II · Moderate risk Terminated

WP Thyroid

Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.

RLC Labs Inc. NDC 64727-5950-2 D-1613-2020