PrimeZEN Black 6000 capsule recalled over undeclared sildenafil

Recall date

February 13, 2023

Source

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

Official notice title

Volt Candy Wholesale Club recalls PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime P…

Recall number

D-0453-2023

FDA classification

Class I

Brand / firm

Volt Candy Wholesale Club

Sold / distributed

Nationwide in the USA

Why it was recalled

Marketed Without An Approved NDA/ANDA: FDA analysis found the 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

PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1.