Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Manufacturing (cGMP) deviations

Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards.

1,754 FDA drug recalls with this cause, newest first.

This category covers departures from current Good Manufacturing Practice during production. It is FDA's broadest label, used when a facility's own process control failed somewhere along the line even if no single ingredient was proven unsafe on its own. Where the report names a specific consequence - a temperature excursion, a contaminant, a potency problem - we file the recall under that more specific cause instead; what remains here is the genuinely general case.

Class II · Moderate risk

Cystex Tablet

CGMP Deviations

Terminated cGMP deviation ULTRAtab Laboratories, Inc. D-0555-2022
Class II · Moderate risk

Back Relief II

CGMP Deviations

Terminated cGMP deviation ULTRAtab Laboratories, Inc. NDC 62959-740-00 D-0551-2022
Class II · Moderate risk

Normed Fem Tablet

CGMP Deviations

Terminated cGMP deviation ULTRAtab Laboratories, Inc. NDC 62959-701-00 D-0549-2022
Class II · Moderate risk

APAP 325 mg

CGMP Deviations

Terminated cGMP deviation ULTRAtab Laboratories, Inc. NDC 62959-700-00 D-0548-2022
Class II · Moderate risk

Migrenol Caplet

CGMP Deviations

Terminated cGMP deviation ULTRAtab Laboratories, Inc. NDC 62959-565-00 D-0547-2022
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