PlainRecalls
FDA Drug Critical Class I Ongoing

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

Reported: May 10, 2023 Initiated: April 26, 2023 #D-0572-2023

Product Description

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

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.

Details

Recalling Firm
Gadget Island, Inc
Units Affected
18 blister cards
Distribution
Nationwide in the USA.
Location
West Sacramento, CA

Frequently Asked Questions

What product was recalled?
NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.. Recalled by Gadget Island, Inc. Units affected: 18 blister cards.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 10, 2023. Severity: Critical. Recall number: D-0572-2023.