Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class I drug recalls - the high-risk category

Class I is the FDA's most serious recall category: a reasonable probability that using the product will cause serious health consequences or death. It is a small share of all recalls, but the one to check first if a medication you take appears here.

1,750 recalls, newest first.

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

Zhen Gong Fu

Marketed Without An Approved NDA/ANDA

Terminated Unapproved drug R Thomas Marketing, LLC D-0907-2016
Class I · High risk

Super Hard

Marketed Without An Approved NDA/ANDA

Terminated Unapproved drug R Thomas Marketing, LLC D-0906-2016
Class I · High risk

Samurai-X

Marketed Without An Approved NDA/ANDA

Terminated Unapproved drug R Thomas Marketing, LLC D-0905-2016
Class I · High risk

Tiger King

Marketed Without An Approved NDA/ANDA

Terminated Unapproved drug R Thomas Marketing, LLC D-0904-2016
Class I · High risk

Night Man

Marketed Without An Approved NDA/ANDA

Terminated Unapproved drug R Thomas Marketing, LLC D-0903-2016
Class I · High risk

Mojo Risen

Marketed Without An Approved NDA/ANDA

Terminated Unapproved drug R Thomas Marketing, LLC D-0902-2016
Class I · High risk

Man King

Marketed Without An Approved NDA/ANDA

Terminated Unapproved drug R Thomas Marketing, LLC D-0901-2016
Class I · High risk

Hard Ten Days

Marketed Without An Approved NDA/ANDA

Terminated Unapproved drug R Thomas Marketing, LLC D-0900-2016
Class I · High risk

Plant Vigra

Marketed Without An Approved NDA/ANDA

Terminated Unapproved drug R Thomas Marketing, LLC D-0899-2016
Class I · High risk

Germany Niubian

Marketed Without An Approved NDA/ANDA

Terminated Unapproved drug R Thomas Marketing, LLC D-0897-2016
Class I · High risk

Black Storm

Marketed Without An Approved NDA/ANDA

Terminated Unapproved drug R Thomas Marketing, LLC D-0896-2016
Class I · High risk

Black Ant King

Marketed Without An Approved NDA/ANDA

Terminated Unapproved drug R Thomas Marketing, LLC D-0895-2016
Class I · High risk

Bull's Genital

Marketed Without An Approved NDA/ANDA

Terminated Unapproved drug R Thomas Marketing, LLC D-0891-2016
Class I · High risk

Bull

Marketed Without An Approved NDA/ANDA

Terminated Unapproved drug R Thomas Marketing, LLC D-0890-2016
Class I · High risk

Weekend Prince

Marketed Without An Approved NDA/ANDA

Terminated Unapproved drug R Thomas Marketing, LLC D-0888-2016
Class I · High risk

Stree Overlord

Marketed Without An Approved NDA/ANDA

Terminated Unapproved drug R Thomas Marketing, LLC D-0887-2016

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