US Drug Recall Register
Class I · High risk Terminated Initiated Mar 30, 2021 (5 years ago)

Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA…

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

Why it was recalled

Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

What was recalled

Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185

Recalling firm
Ummzy, LLC
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0663-2021

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.