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

1 recalls · Class III, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2011 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class III · Low risk

Azelastine HCl Nasal Solution

CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.

Terminated cGMP deviation Apotex Corp. NDC 60505-0833-5 D-1667-2012

Recalls by year