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

11,818 recalls · Class II, 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

Tadalafil Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-369-10 D-0414-2023
Class II · Moderate risk

Simvastatin Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-004-15 D-0409-2023
Class II · Moderate risk

Rosuvastatin Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-287-10 D-0407-2023
Class II · Moderate risk

Rosuvastatin Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-286-15 D-0406-2023
Class II · Moderate risk

Rosuvastatin Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-285-15 D-0405-2023
Class II · Moderate risk

Rosuvastatin Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-284-15 D-0404-2023
Class II · Moderate risk

Montelukast Sodium Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-119-10 D-0400-2023
Class II · Moderate risk

Glycopyrrolate Injection

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-474-05 D-0399-2023
Class II · Moderate risk

Glycopyrrolate Injection

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-473-31 D-0398-2023
Class II · Moderate risk

Glycopyrrolate Injection

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-472-30 D-0397-2023
Class II · Moderate risk

Glycopyrrolate Injection

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-471-63 D-0396-2023
Class II · Moderate risk

Glimepiride Tablets USP

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-003-01 D-0395-2023
Class II · Moderate risk

Glimepiride Tablets USP

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-002-01 D-0394-2023
Class II · Moderate risk

Glimepiride Tablets USP

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-001-01 D-0393-2023
Class II · Moderate risk

Finasteride Tablets USP

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-090-10 D-0392-2023
Class II · Moderate risk

Finasteride Tablets USP 1 mg

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 71713-096-90 D-0391-2023
Class II · Moderate risk

Finasteride Tablets USP

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-089-10 D-0390-2023

Recalls by year