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

FDA recall notice · announced March 2, 2022 · Positive Health

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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

Reason for recall

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.

Notes

Distribution: Product was distributed nationwide via the internet through Amazon Marketplace.
Lot/code information: Lot # 48658908, Exp. date 09/09/2023
Quantity: 5,500 cartons
Status: Terminated
Products in this recall event:
- RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1. (D-0645-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.