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 2012 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class I · High risk

HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS

Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.

Ongoing Wrong potency / content Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals NDC 0603-3888-21 D-057-2013
Class I · High risk

Blue Male Enhancement Pill

Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug

Ongoing Chemical / undeclared The Menz Club, LLC D-266-2013

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