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

5 recalls · Class I, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2012 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class I · High risk

Isovue -300

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

Terminated Particulate / foreign matter Bracco Diagnostic Inc NDC 0270-1315-67 D-158-2013
Class I · High risk

Isovue -370

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

Terminated Particulate / foreign matter Bracco Diagnostic Inc NDC 0270-1316-66 D-157-2013
Class I · High risk

Trastuzumab Kit containing 1 vial Trastuzumab

Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates.

Terminated Particulate / foreign matter Genentech Inc NDC 50242-903-69 D-135-2013

Recalls by year