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

FDA recall notice · announced February 23, 2022 · Celebrate Today

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

The product

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

Reason for recall

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.

Notes

Distribution: Product was distributed nationwide in the USA via Amazon Marketplace
Lot/code information: Lot # DK1027, Exp. 08/01/2023
Quantity: 500 cartons
Status: Terminated
Products in this recall event:
- RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5. (D-0638-2022)

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