Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

775 recalls, newest first

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

Simvastatin

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 61919-0710-90 D-0483-2023
Class II · Moderate risk

Glimepiride

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 61919-0250-30 D-0482-2023
Class II · Moderate risk

Glimepiride

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 61919-0488-30 D-0481-2023
Class II · Moderate risk

Glimepiride

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 61919-0723-30 D-0480-2023
Class II · Moderate risk

Ropinirole

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 72189-0364-30 D-0479-2023
Class II · Moderate risk

Ropinirole

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 72189-0364-30 D-0478-2023
Class II · Moderate risk

Finasteride

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 61919-0733-90 D-0477-2023
Class II · Moderate risk

Calcitonin Salmon Nasal Spray

Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.

Terminated Impurity / degradation Endo Pharmaceuticals, Inc. NDC 49884-161-11 D-0475-2023
Class II · Moderate risk

Clobazam Tablets

CGMP Deviations: Potential risk of Cross Contamination

Terminated Cross-contamination Breckenridge Pharmaceutical, Inc NDC 51991-901-01 D-0463-2023
Class II · Moderate risk

Clobazam Tablets

CGMP Deviations: Potential risk of Cross Contamination

Terminated Cross-contamination Breckenridge Pharmaceutical, Inc NDC 51991-900-01 D-0462-2023
Class II · Moderate risk

Alprazolam Tablets

CGMP Deviations: Potential risk of Cross Contamination

Terminated Cross-contamination Breckenridge Pharmaceutical, Inc NDC 51991-0707-01 D-0461-2023
Class II · Moderate risk

Alprazolam Tablets

CGMP Deviations: Potential risk of Cross Contamination

Terminated Cross-contamination Breckenridge Pharmaceutical, Inc NDC 51991-0706-01 D-0460-2023
Class II · Moderate risk

Alprazolam Tablets

CGMP Deviations: Potential risk of Cross Contamination

Terminated Cross-contamination Breckenridge Pharmaceutical, Inc NDC 51991-0705-01 D-0459-2023
Class II · Moderate risk

Alprazolam Tablets

CGMP Deviations: Potential risk of Cross Contamination

Terminated Cross-contamination Breckenridge Pharmaceutical, Inc NDC 51991-0704-01 D-0458-2023
Class III · Low risk

Colchicine Tablets

Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.

Terminated Impurity / degradation Zydus Pharmaceuticals (USA) Inc NDC 16714-0039-01 D-0467-2023

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