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

6,161 recalls · Class II, 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

PHENYLephrine 1

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. D-1124-2023
Class II · Moderate risk

Cardioplegia Solution

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. D-1123-2023
Class II · Moderate risk

rocuronium 50 mg/5 mL

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. NDC 72196-6010-1 D-1113-2023
Class II · Moderate risk

Cardioplegia Solution

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. D-1111-2023
Class II · Moderate risk

Cardioplegia Solution

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. D-1110-2023
Class II · Moderate risk

Cardioplegia Solution

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. D-1109-2023
Class II · Moderate risk

Cardioplegia Solution

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. D-1108-2023
Class II · Moderate risk

Cardioplegia Solution

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. D-1107-2023
Class II · Moderate risk

DIANEAL Low Calcium

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

Terminated Sterility / contamination Baxter Healthcare Corporation NDC 0941-0409-06 D-1140-2023

Recalls by year