THE RED PILL recalled over undeclared tadalafil

Recall date

February 8, 2022

Source

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

Official notice title

Your Favorite Shop recalls THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Bar…

Recall number

D-0630-2022

FDA classification

Class I

Brand / firm

Your Favorite Shop

Sold / distributed

Product was distributed nationwide in the USA via the internet through 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

THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Barcode X002G5GMJ1.