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

Clopidogrel Tablets USP

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-218-10 D-0380-2023
Class II · Moderate risk

Aripiprazole Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-283-10 D-0370-2023
Class II · Moderate risk

Aripiprazole Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-282-10 D-0369-2023
Class II · Moderate risk

Aripiprazole Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-281-10 D-0368-2023
Class II · Moderate risk

Aripiprazole Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-280-10 D-0367-2023
Class II · Moderate risk

Aripiprazole Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-279-10 D-0366-2023
Class II · Moderate risk

Aripiprazole Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-278-10 D-0365-2023
Class II · Moderate risk

Delsam Pharma's ARTIFICIAL TEARS

CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.

Ongoing cGMP deviation Global Pharma Healthcare Private Limited D-0922-2023
Class II · Moderate risk

Artificial Tears

CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.

Ongoing cGMP deviation Global Pharma Healthcare Private Limited NDC 79503-0101-15 D-0920-2023
Class II · Moderate risk

Ohm Sanitizer Spray

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Terminated cGMP deviation Urban Electric Power D-0264-2023
Class II · Moderate risk

Ohm Hand Sanitizer

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Terminated cGMP deviation Urban Electric Power D-0263-2023
Class II · Moderate risk

Hand Sanitizer

CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.

Ongoing cGMP deviation Fisher Scientific Co., LLC D-0164-2023
Class II · Moderate risk

Hand Sanitizer

CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.

Ongoing cGMP deviation Fisher Scientific Co., LLC D-0163-2023
Class II · Moderate risk

Sterile Water for Injection

CGMP Deviations: potential for trace amounts of product carryover.

Terminated cGMP deviation Nephron Sc Inc NDC 0487-6105-01 D-0178-2023