PremierZen Black 5000 Capsules (Namoo) – Unapproved Drug Ingredients (2021)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006 UPC 7 2817542189 4
Brand
Namoo Enterprise LLC
Lot Codes / Batch Numbers
All lots within expiry
Products Sold
All lots within expiry
Namoo Enterprise LLC is recalling PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier G due to Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026