RED MAMMOTH capsules recalled over undeclared sildenafil

Recall date

February 8, 2022

Source

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

Official notice title

Celebrate Today recalls RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.

Recall number

D-0638-2022

FDA classification

Class I

Brand / firm

Celebrate Today

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 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

RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.