US Drug Recall Register
Class I · High risk Terminated Initiated Feb 8, 2022 (5 years ago)

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

Class I — High risk. Reasonable probability of serious harm or death.

Why it was 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.

What was recalled

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

Recalling firm
Celebrate Today
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0638-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.