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

Liceout

CGMP violations.

Ongoing cGMP deviation Neogen Corporation D-0074-2025
Class II · Moderate risk

Liceout

CGMP violations.

Ongoing cGMP deviation Neogen Corporation D-0073-2025
Class II · Moderate risk

Pluvicto

CGMP deviations

Ongoing cGMP deviation Advanced Accelerator Applications USA, Inc. NDC 69488-0010-61 D-0007-2025
Class II · Moderate risk

Glenmark

CGMP Deviations

Ongoing cGMP deviation Glenmark Pharmaceuticals Inc., USA NDC 68462-626-52 D-0621-2024
Class II · Moderate risk

Blemfree All Day Lotion

CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.

Terminated cGMP deviation Equibal Inc NDC 53228-002-01 D-0591-2024