Independent register of U.S. FDA drug recalls · updated Oct 11, 2026
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Class II drug recalls - moderate risk

Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.

14,535 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

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
Class II · Moderate risk

Doxazosin Tablets USP

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-415-01 D-0389-2023
Class II · Moderate risk

Doxazosin Tablets USP

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-213-01 D-0388-2023
Class II · Moderate risk

Doxazosin Tablets USP

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-414-01 D-0387-2023
Class II · Moderate risk

Doxazosin Tablets USP 1 mg

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-211-01 D-0386-2023
Class II · Moderate risk

Dofetilide Capsules 500 mcg

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-492-12 D-0385-2023
Class II · Moderate risk

Dofetilide Capsules 250 mcg

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-491-12 D-0384-2023
Class II · Moderate risk

Dofetilide Capsules

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-490-12 D-0383-2023
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

Recalls by year