PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: February 23, 2022 Initiated: February 8, 2022 #D-0638-2022

Product Description

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.

Details

Recalling Firm
Celebrate Today
Units Affected
500 cartons
Distribution
Product was distributed nationwide in the USA via Amazon Marketplace
Location
Brentwood, NY

Frequently Asked Questions

What product was recalled?
RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.. Recalled by Celebrate Today. Units affected: 500 cartons.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 23, 2022. Severity: Critical. Recall number: D-0638-2022.