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

775 recalls, newest first

Class II · Moderate risk

Pirfenidone Tablets 801 mg

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-468-15 D-0420-2023
Class II · Moderate risk

Vigabatrin for Oral Solution

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-521-63 D-0418-2023
Class II · Moderate risk

Tadalafil Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-372-10 D-0417-2023
Class II · Moderate risk

Tadalafil Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-371-10 D-0416-2023
Class II · Moderate risk

Tadalafil Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-370-10 D-0415-2023
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

Recalls by year