US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

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

Cardioplegia Solution

Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Central Admixture Pharmacy Services, Inc. NDC 71285-0104-1 D-0662-2023
Class II · Moderate risk Terminated

Cardioplegia Solution

Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Central Admixture Pharmacy Services, Inc. NDC 71285-0103-1 D-0661-2023
Class II · Moderate risk Terminated

Cardioplegia Solution

Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Central Admixture Pharmacy Services, Inc. NDC 71285-0102-1 D-0660-2023
Class II · Moderate risk Terminated

Cardioplegia Solution

Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Central Admixture Pharmacy Services, Inc. NDC 71285-0101-1 D-0659-2023
Class II · Moderate risk Terminated

Cardioplegia Solution

Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Central Admixture Pharmacy Services, Inc. NDC 71285-0100-1 D-0658-2023
Class II · Moderate risk Terminated

Transplant Solution

Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Central Admixture Pharmacy Services, Inc. NDC 71285-0014-2 D-0657-2023
Class II · Moderate risk Terminated

Microplegia Solution

Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Central Admixture Pharmacy Services, Inc. NDC 71285-0012-2 D-0656-2023
Class II · Moderate risk Terminated

Cardioplegia Solution

Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Central Admixture Pharmacy Services, Inc. NDC 71285-0011-1 D-0655-2023
Class II · Moderate risk Terminated

Cardioplegia Solution

Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Central Admixture Pharmacy Services, Inc. NDC 71285-0009-1 D-0654-2023
Class II · Moderate risk Terminated

Cardioplegia Solution

Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Central Admixture Pharmacy Services, Inc. NDC 71285-0008-1 D-0653-2023
Class II · Moderate risk Terminated

Cardioplegia Solution

Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Central Admixture Pharmacy Services, Inc. NDC 71285-0007-1 D-0652-2023
Class II · Moderate risk Terminated

Cardioplegia Solution

Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Central Admixture Pharmacy Services, Inc. NDC 71285-0006-1 D-0651-2023
Class II · Moderate risk Terminated

Cardioplegia Solution

Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Central Admixture Pharmacy Services, Inc. NDC 71285-0005-1 D-0650-2023
Class II · Moderate risk Terminated

Cardioplegia Solution

Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Central Admixture Pharmacy Services, Inc. NDC 71285-0002-1 D-0649-2023
Class II · Moderate risk Terminated

Microplegia

Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Central Admixture Pharmacy Services, Inc. NDC 71285-0001-1 D-0648-2023
Class II · Moderate risk Terminated

Fyremadel

Reason Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.

Sun Pharmaceutical Industries Ltd. NDC 55566-1010-1 D-0569-2023
Class II · Moderate risk Terminated

Simvastatin USP 40 mg

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-0726-30 D-0561-2023
Class II · Moderate risk Terminated

Simvastatin USP 20 mg

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-008-30 D-0560-2023
Class II · Moderate risk Terminated

Glimepiride USP

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-0587-90 D-0559-2023
Class II · Moderate risk Terminated

Simvastatin USP

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-0727-30 D-0558-2023
Class II · Moderate risk Terminated

Montelukast Sodium USP

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-0762-30 D-0557-2023
Class II · Moderate risk Terminated

Isopropyl Alcohol Antiseptic 75%

Reason CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.

Jarman's Midwest Cleaning Systems, Inc. D-0872-2023
Class II · Moderate risk Terminated

Alprazolam Tab

Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.

Preferred Pharmaceuticals, Inc. NDC 68788-7596-3 D-0506-2023
Class II · Moderate risk Terminated

Alprazolam Tab

Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.

Preferred Pharmaceuticals, Inc. NDC 68788-7595-3 D-0505-2023
Class II · Moderate risk Terminated

Alprazolam Tab

Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.

Preferred Pharmaceuticals, Inc. NDC 68788-7594-3 D-0504-2023