Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

FDA Drug Recalls

1,590 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2018 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Ibuprofen Tablets

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Terminated cGMP deviation Time-Cap Laboratories, Inc. NDC 53943-291-15 D-0686-2018
Class II · Moderate risk

Ibuprofen Tablets

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Terminated cGMP deviation Time-Cap Laboratories, Inc. NDC 49483-601-05 D-0685-2018
Class II · Moderate risk

Aripiprazole Tablets

CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.

Terminated cGMP deviation Hetero Labs, Ltd. - Unit III NDC 31722-827-30 D-0594-2018
Class II · Moderate risk

Ibuprofen Tablets USP

CGMP deviations: Ibuprofen is being recalled in response to previous recall

Terminated cGMP deviation Spirit Pharmaceuticals, LLC NDC 68210-0800-1 D-0583-2018
Class II · Moderate risk

Ibuprofen Tablets

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Terminated cGMP deviation Marksans Pharma Inc. NDC 25000-123-27 D-0240-2018
Class II · Moderate risk

Ibuprofen Tablets

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Terminated cGMP deviation Marksans Pharma Inc. NDC 25000-122-28 D-0239-2018
Class II · Moderate risk

Ibuprofen Tablets

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Terminated cGMP deviation Marksans Pharma Inc. NDC 25000-121-29 D-0238-2018
Class II · Moderate risk

Ibuprofen Tablets

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Terminated cGMP deviation Marksans Pharma Inc. NDC 25000-114-30 D-0237-2018
Class II · Moderate risk

Ibuprofen Tablets

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Terminated cGMP deviation Marksans Pharma Inc. NDC 25000-136-20 D-0236-2018
Class II · Moderate risk

Ibuprofen Tablets

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Terminated cGMP deviation Marksans Pharma Inc. NDC 25000-117-30 D-0235-2018
Class I · High risk

Clopidogrel Tablets

LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.

Terminated Labeling / mix-up International Laboratories, LLC NDC 54458-888-16 D-0472-2018
Class II · Moderate risk

Lovastatin Tablets USP

Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.

Terminated Dissolution failure AVKARE Inc. NDC 50268-512-15 D-0222-2018

Recalls by year