US Drug Recall Register
Class I · High risk Ongoing Initiated Mar 29, 2021 (5 years ago)

Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri…

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

Why it was recalled

Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

What was recalled

Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC

Recalling firm
Nuri Trading LLC
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0685-2021

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.