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

Humatrix Microclysmic Gel

CGMP Deviations: initiated due to violations of CGMP manufacturing practices

Ongoing cGMP deviation Consolidated Chemical, Inc D-0326-2023
Class II · Moderate risk

Menastil

cGMP Deviations

Terminated cGMP deviation Atlantic Management Resources Ltd. NDC 66233-711-01 D-0084-2023
Class II · Moderate risk

ProSirona

cGMP Deviations

Terminated cGMP deviation Atlantic Management Resources Ltd. NDC 66233-712-01 D-0083-2023
Class II · Moderate risk

Neuroquell

cGMP Deviations

Terminated cGMP deviation Atlantic Management Resources Ltd. D-0082-2023
Class II · Moderate risk

Neuroquell Plus

cGMP Deviations

Terminated cGMP deviation Atlantic Management Resources Ltd. D-0081-2023