MegMan Performance Booster recalled over undeclared tadalafil

Recall date

February 4, 2022

Source

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

Official notice title

Junp Hydration LLC recalls MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, A…

Recall number

D-0557-2022

FDA classification

Class I

Brand / firm

Junp Hydration LLC

Sold / distributed

Product was distributed nationwide in the USA via Amazon Marketplace

Why it was recalled

Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient 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

MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, ASIN B08Z74KS88