RISE UP RED EDITION Capsules recalled over undeclared tadalafil

Recall date

February 10, 2022

Source

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

Official notice title

Positive Health recalls RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.

Recall number

D-0645-2022

FDA classification

Class I

Brand / firm

Positive Health

Sold / distributed

Product was distributed nationwide 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

RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.