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

2 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2007 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Leflunomide tablets

Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.

Terminated Wrong potency / content Apotex Corp. NDC 60505-2503-3 D-1662-2012
Class II · Moderate risk

Leflunomide tablets

Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.

Terminated Wrong potency / content Apotex Corp. NDC 60505-2502-1 D-1661-2012

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