PremierZen Extreme 3000 — Class II drug recall D-0369-2021
Ongoing recall by QMart, reported 2021-05-12, distributed nationwide. Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
| Recall number | D-0369-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | QMart, Elmwood Park, NJ, United States |
| Recall initiated | 2021-03-31 |
| Classified | 2021-05-06 |
| Reported by FDA | 2021-05-12 |
| Distributed | Nationwide (US) |
| Quantity | 500 boxes |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00728175421887 |
Product
PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887
Reason for recall
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or 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-0369-2021. 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.