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

Methocarbamol

CGMP Deviations: Lack of quality assurance at the API manufacturer.

Terminated cGMP deviation American Pharmaceutical Ingredients LLC D-0937-2017
Class II · Moderate risk

Estrone USP

cGMP Deviations; lack of quality assurance.

Terminated cGMP deviation American Pharmaceutical Ingredients LLC D-0919-2017
Class II · Moderate risk

Levonorgestrel

CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.

Terminated cGMP deviation Spectrum Laboratory Products, Inc. D-0882-2017
Class II · Moderate risk

Estradiol (17-B-Estradiol; Estra-1,3,5(10)

CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.

Terminated cGMP deviation Spectrum Laboratory Products, Inc. D-0881-2017
Class II · Moderate risk

Estrone

cGMP Deviations: lack of quality assurance at the API manufacturer.

Terminated cGMP deviation Fagron, Inc NDC 51552-0445-2 D-0792-2017
Class II · Moderate risk

Estriol

cGMP Deviations: lack of quality assurance at the API manufacturer.

Terminated cGMP deviation Fagron, Inc NDC 52372-9292-01 D-0791-2017
Class II · Moderate risk

Estradiol

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

Terminated cGMP deviation Medisca, Inc. NDC 38779-2261-04 D-0666-2017
Class II · Moderate risk

Estradiol

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

Terminated cGMP deviation Medisca, Inc. NDC 38779-0869-07 D-0665-2017
Class II · Moderate risk

Estrone

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

Terminated cGMP deviation Medisca, Inc. NDC 38779-0891-05 D-0664-2017
Class II · Moderate risk

Estriol

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

Terminated cGMP deviation Medisca, Inc. NDC 38779-0732-03 D-0663-2017
Class II · Moderate risk

Testosterone Micronized

cGMP Deviations; lack of quality assurance.

Terminated cGMP deviation Qinhuangdao Zizhu Pharmaceutical, Co. NDC 44132-006-06 D-0658-2017
Class II · Moderate risk

Estrone Micronized

cGMP Deviations; lack of quality assurance.

Terminated cGMP deviation Qinhuangdao Zizhu Pharmaceutical, Co. NDC 44132-003-04 D-0657-2017