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

515 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

Cardioplegia Solution

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

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. NDC 71285-0107-1 D-0665-2023
Class II · Moderate risk

Cardioplegia Solution

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

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. NDC 71285-0106-1 D-0664-2023
Class II · Moderate risk

Cardioplegia Solution

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

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. NDC 71285-0105-1 D-0663-2023
Class II · Moderate risk

Cardioplegia Solution

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

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

Cardioplegia Solution

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

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

Cardioplegia Solution

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

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

Cardioplegia Solution

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

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

Cardioplegia Solution

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

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

Transplant Solution

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

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

Microplegia Solution

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

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

Cardioplegia Solution

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

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

Cardioplegia Solution

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

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

Cardioplegia Solution

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

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

Cardioplegia Solution

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

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

Cardioplegia Solution

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

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

Cardioplegia Solution

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

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

Cardioplegia Solution

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

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

Microplegia

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

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

Admelog

Lack of Assurance of Sterility: Malformed crimped collar seal

Ongoing Sterility / contamination Sanofi-Aventis U.S. LLC NDC 0024-5926-05 D-0575-2023
Class II · Moderate risk

Dianeal Low Calcium

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Completed Sterility / contamination Baxter Healthcare Corporation NDC 0941-0409-07 D-0542-2023

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