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

26 recalls, 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 ยท High risk

5K Premium Enhancement capsule

Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil

Terminated Chemical / undeclared Happy Together, Inc. D-0388-2019

Recalls by year