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

Pyrazinamide

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Ongoing cGMP deviation RemedyRepack Inc. NDC 70518-2534-01 D-0578-2023
Class II · Moderate risk

Ketotifen Fumarate 0.025 %

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Ongoing cGMP deviation RemedyRepack Inc. NDC 70518-1142-00 D-0577-2023
Class II · Moderate risk

LORazepam Injection

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Terminated cGMP deviation RemedyRepack Inc. NDC 17478-0040-01 D-0576-2023
Class II · Moderate risk

Pantoprazole sodium for Injection 40 mg*/vial

CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.

Completed cGMP deviation Methapharm Inc NDC 67850-150-10 D-0540-2023
Class II · Moderate risk

Glimepiride USP

CGMP deviations.

Terminated cGMP deviation PD-Rx Pharmaceuticals, Inc. NDC 43063-0587-90 D-0559-2023
Class II · Moderate risk

Simvastatin USP

CGMP deviations.

Terminated cGMP deviation PD-Rx Pharmaceuticals, Inc. NDC 43063-0727-30 D-0558-2023
Class II · Moderate risk

Glimepiride Tablets USP

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-8066-9 D-0527-2023
Class II · Moderate risk

Tadalafil Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-8153-7 D-0526-2023
Class II · Moderate risk

Simvastatin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-9868-9 D-0525-2023
Class II · Moderate risk

Simvastatin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-9869-9 D-0524-2023
Class II · Moderate risk

Simvastatin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-9429-9 D-0523-2023
Class II · Moderate risk

Simvastatin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-9747-9 D-0522-2023
Class II · Moderate risk

Pravastatin Sodium Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-8215-9 D-0521-2023
Class II · Moderate risk

Rosuvastatin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-7971-3 D-0520-2023
Class II · Moderate risk

Rosuvastatin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-7086-3 D-0519-2023
Class II · Moderate risk

Montelukast Sodium Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-9438-3 D-0518-2023
Class II · Moderate risk

Glimepiride Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-8095-9 D-0517-2023
Class II · Moderate risk

Finasteride Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-6976-3 D-0516-2023
Class II · Moderate risk

Doxazosin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-7149-1 D-0515-2023
Class II · Moderate risk

Doxazosin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-7328-1 D-0514-2023
Class II · Moderate risk

Clopidogrel Tablets USP

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-8190-9 D-0513-2023
Class II · Moderate risk

Atorvastatin Calcium Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-7631-9 D-0512-2023