FDA Recall D-0572-2023

Gadget Island, Inc · West Sacramento, CA

Class I — life-threatening Ongoing 1114 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

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

Lot / code: Lot#: RO 927996, Exp: 12/25/2024

Quantity: 18 blister cards

Reason for recall

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.

Recall record

Recall number: D-0572-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA.
Recall initiated: 2023-04-26
Classified by FDA Center: 2023-05-11
FDA published: 2023-05-10
Recalling firm: Gadget Island, Inc
Firm location: West Sacramento, CA

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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