Male Ultra Pro — Class I drug recall D-0467-2025
Ongoing recall by SAINI TRADE INC, reported 2025-06-18, distributed nationwide. Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared pro
| Recall number | D-0467-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SAINI TRADE INC, Tempe, AZ, United States |
| Recall initiated | 2025-04-14 |
| Classified | 2025-06-11 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 300 boxes |
| Reason classes | undeclared allergen, unapproved product |
| Lot numbers | KT-1ST-43-0110/2025 |
| Expiration dates | 2026-03-15 |
Product
Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
Reason for recall
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil 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-0467-2025. 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.