US Drug Recall Register
Class I · High risk Ongoing Initiated Apr 8, 2021 (5 years ago)

Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co…

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 sildenafil and/ or tadalafil

What was recalled

Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 32555 7

Recalling firm
NSNY Distributor Inc
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0641-2021

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.