FDA recall D-0573-2023

Product

DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.

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-0573-2023