MAC DADDY RED Capsules recalled over undeclared tadalafil

Recall date

February 8, 2022

Source

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

Official notice title

ABC Sales 1 Inc recalls MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.

Recall number

D-0562-2022

FDA classification

Class I

Brand / firm

ABC Sales 1 Inc

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 and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.

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

MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.