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

1 recalls · Class I, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2018 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class I · High risk

Montelukast Sodium Tablets 10 mg

Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.

Ongoing Labeling / mix-up Hetero Labs Limited Unit V NDC 31722-726-30 D-0081-2019

Recalls by year