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

Florbetaben F-18

Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).

Terminated Sterility / contamination Sofie Co dba Sofie NDC 54828-001-50 D-1177-2023
Class II · Moderate risk

dilTIAZem 125mg/125mL

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

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. D-1138-2023
Class II · Moderate risk

dilTIAZem 125mg/125mL

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

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. D-1137-2023
Class II · Moderate risk

oxyTOCIN

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

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. D-1134-2023
Class II · Moderate risk

EPINEPHrine

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

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. D-1129-2023
Class II · Moderate risk

PHENYLephrine

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

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. D-1127-2023
Class II · Moderate risk

PHENYLephrine

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

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. D-1125-2023

Recalls by year