Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

207 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Safe tussin PM

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Ongoing cGMP deviation Denison Pharmaceuticals, LLC D-0775-2023
Class II · Moderate risk

Pin-Away PYRENTAL PAMOATE

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Ongoing cGMP deviation Denison Pharmaceuticals, LLC NDC 70309-080-02 D-0774-2023
Class II · Moderate risk

Colic Calm

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Ongoing cGMP deviation Denison Pharmaceuticals, LLC D-0773-2023
Class II · Moderate risk

Safe tussin DM

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Ongoing cGMP deviation Denison Pharmaceuticals, LLC D-0772-2023
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

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