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

Ibuprofen Tablets

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Terminated cGMP deviation Time-Cap Laboratories, Inc. NDC 53943-291-15 D-0686-2018
Class II · Moderate risk

Ibuprofen Tablets

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Terminated cGMP deviation Time-Cap Laboratories, Inc. NDC 49483-601-05 D-0685-2018
Class II · Moderate risk

Aripiprazole Tablets

CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.

Terminated cGMP deviation Hetero Labs, Ltd. - Unit III NDC 31722-827-30 D-0594-2018
Class II · Moderate risk

Ibuprofen Tablets USP

CGMP deviations: Ibuprofen is being recalled in response to previous recall

Terminated cGMP deviation Spirit Pharmaceuticals, LLC NDC 68210-0800-1 D-0583-2018
Class II · Moderate risk

Ibuprofen Tablets

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Terminated cGMP deviation Marksans Pharma Inc. NDC 25000-123-27 D-0240-2018
Class II · Moderate risk

Ibuprofen Tablets

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Terminated cGMP deviation Marksans Pharma Inc. NDC 25000-122-28 D-0239-2018
Class II · Moderate risk

Ibuprofen Tablets

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Terminated cGMP deviation Marksans Pharma Inc. NDC 25000-121-29 D-0238-2018
Class II · Moderate risk

Ibuprofen Tablets

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Terminated cGMP deviation Marksans Pharma Inc. NDC 25000-114-30 D-0237-2018
Class II · Moderate risk

Ibuprofen Tablets

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Terminated cGMP deviation Marksans Pharma Inc. NDC 25000-136-20 D-0236-2018
Class II · Moderate risk

Ibuprofen Tablets

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Terminated cGMP deviation Marksans Pharma Inc. NDC 25000-117-30 D-0235-2018
Class II · Moderate risk

Estriol

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

Terminated cGMP deviation Fagron, Inc NDC 51552-1392-5 D-0079-2018
Class I · High risk

PIYANPING Anti-Itch

Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.

Terminated cGMP deviation Lucky Mart Inc. NDC 68085-8012-4 D-0031-2018