PremierZen Black 5000 capsules — Class II drug recall D-0351-2021
Terminated recall by Namoo Enterprise LLC, reported 2021-05-05, distributed nationwide. Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
| Recall number | D-0351-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Namoo Enterprise LLC, Little Ferry, NJ, United States |
| Recall initiated | 2021-03-25 |
| Classified | 2021-04-26 |
| Reported by FDA | 2021-05-05 |
| Terminated | 2021-07-16 |
| Distributed | Nationwide (US) |
| Reason classes | unapproved product |
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
Reason for recall
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0351-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.