NUX Male Enhancement capsule recalled over undeclared sildenafil

Recall date

April 26, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

D-0572-2023

FDA classification

Class I

Brand / firm

Gadget Island, Inc

Sold / distributed

Nationwide in the USA.

Why it was 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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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