PrimeZEN Black 6000 capsule — Class I drug recall D-0453-2023
Terminated recall by Volt Candy Wholesale Club, reported 2023-03-08, distributed nationwide. Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil
| Recall number | D-0453-2023 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volt Candy Wholesale Club, Diamond Bar, CA, United States |
| Recall initiated | 2023-02-13 |
| Classified | 2023-03-09 |
| Reported by FDA | 2023-03-08 |
| Terminated | 2024-08-20 |
| Distributed | Nationwide (US) |
| Quantity | 432 capsules |
| Reason classes | undeclared allergen, unapproved product |
| UPC / GTIN / UDI-DI | 00728175521891 |
| Expiration dates | 2025-08-16 |
Product
PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1.
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
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-0453-2023. 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.