US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

rOPINIRole Tablets USP 0.25 mg*

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-232-01 D-0425-2023
Class II · Moderate risk Terminated

Pravastatin Sodium Tablets USP

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-011-15 D-0424-2023
Class II · Moderate risk Terminated

Pravastatin Sodium Tablets USP

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-010-17 D-0423-2023
Class II · Moderate risk Terminated

Pravastatin Sodium Tablets USP 20 mg

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-009-15 D-0422-2023
Class II · Moderate risk Terminated

Pravastatin Sodium Tablets USP

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-008-15 D-0421-2023
Class II · Moderate risk Terminated

Pirfenidone Tablets 801 mg

Reason CGMP Deviations: recalling drug products following an FDA inspection.

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

Vigabatrin for Oral Solution

Reason CGMP Deviations: recalling drug products following an FDA inspection.

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

Tadalafil Tablets

Reason CGMP Deviations: recalling drug products following an FDA inspection.

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

Tadalafil Tablets

Reason CGMP Deviations: recalling drug products following an FDA inspection.

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

Tadalafil Tablets

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-370-10 D-0415-2023
Class II · Moderate risk Terminated

Tadalafil Tablets

Reason CGMP Deviations: recalling drug products following an FDA inspection.

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

Succinylcholine Chloride Injection

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-493-03 D-0413-2023
Class II · Moderate risk Terminated

Simvastatin Tablets USP 80 mg Rx Only

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-007-15 D-0412-2023
Class II · Moderate risk Terminated

Simvastatin Tablets USP 40 mg Rx Only

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-006-15 D-0411-2023
Class II · Moderate risk Terminated

Simvastatin Tablets USP 20 mg Rx Only

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-005-15 D-0410-2023
Class II · Moderate risk Terminated

Simvastatin Tablets

Reason CGMP Deviations: recalling drug products following an FDA inspection.

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

Simvastatin Tablets USP 5 mg Rx Only

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-156-15 D-0408-2023
Class II · Moderate risk Terminated

Rosuvastatin Tablets

Reason CGMP Deviations: recalling drug products following an FDA inspection.

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

Rosuvastatin Tablets

Reason CGMP Deviations: recalling drug products following an FDA inspection.

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

Rosuvastatin Tablets

Reason CGMP Deviations: recalling drug products following an FDA inspection.

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

Rosuvastatin Tablets

Reason CGMP Deviations: recalling drug products following an FDA inspection.

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

Phenylephrine Hydrochloride Injection

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-466-03 D-0403-2023
Class II · Moderate risk Terminated

Phenylephrine Hydrochloride Injection

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-465-31 D-0402-2023
Class II · Moderate risk Terminated

Phenylephrine Hydrochloride Injection

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-464-63 D-0401-2023