FDA recall D-0572-2023

Product

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.

Distribution

Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2023-04-26

Report date

2023-05-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Sacramento, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0572-2023