D-0467-2025 Class I Ongoing
FDA drug recall D-0467-2025 was initiated by SAINI TRADE INC on April 14, 2025 and is designated Class I. Reason for recall: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. The recall status is ongoing. Affected quantity: 300 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- June 18, 2025
- Initiation Date
- April 14, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 300 boxes
Product Description
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.
Distribution Pattern
Nationwide
Code Information
All lots Lot #: KT-1ST-43-0110/2025, Exp. 03/15/2026