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

2 recalls · Class I, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2019 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class I · High risk

Amikacin Sulfate Injection

Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .

Terminated Sterility / contamination Heritage Pharmaceuticals, Inc. NDC 23155-290-32 D-1398-2019
Class I · High risk

Prochlorperazine Edisylate Injection

Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .

Terminated Sterility / contamination Heritage Pharmaceuticals, Inc. NDC 23155-294-31 D-1397-2019

Recalls by year