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Recall Observatory FDA recall evidence

Drug product

NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.

D-0572-2023

April 26, 2023

Class I

Product summary

Firm
Gadget Island, Inc
Event
Event 92203
Status
Ongoing
Classification
Class I
Quantity
18 blister cards
Official record key
drug-enforcement:D-0572-2023

Official wording

Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Code information: Lot#: RO 927996, Exp: 12/25/2024

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.