Independent register of U.S. FDA drug recalls · updated Oct 12, 2026
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Class II drug recalls - moderate risk

Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.

14,535 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

HPC Tablet

CGMP Deviations

Terminated cGMP deviation ULTRAtab Laboratories, Inc. NDC 62969-242-00 D-0538-2022
Class II · Moderate risk

Coated APAP 325mg

CGMP Deviations

Terminated cGMP deviation ULTRAtab Laboratories, Inc. NDC 62959-202-00 D-0532-2022
Class II · Moderate risk

APAP 325 mg

CGMP Deviations

Terminated cGMP deviation ULTRAtab Laboratories, Inc. NDC 62959-200-00 D-0531-2022
Class II · Moderate risk

Zee Cold Tabs

CGMP Deviations

Terminated cGMP deviation ULTRAtab Laboratories, Inc. D-0525-2022
Class II · Moderate risk

Inhub Wixela

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Terminated Temperature excursion Cardinal Healthcare D-0202-2024
Class II · Moderate risk

Warfarin Sodium Tablets

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Terminated Temperature excursion Cardinal Healthcare D-0201-2024
Class II · Moderate risk

Warfarin Sodium Tablets

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Terminated Temperature excursion Cardinal Healthcare D-0200-2024

Recalls by year