Recalls / Class I
Class ID-0467-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
- Affected lot / code info
- All lots Lot #: KT-1ST-43-0110/2025, Exp. 03/15/2026
Why it was recalled
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Recalling firm
- Firm
- SAINI TRADE INC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1405 N Scottsdale Rd, Tempe, Arizona 85288-1714
Distribution
- Quantity
- 300 boxes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2025-04-14
- FDA classified
- 2025-06-11
- Posted by FDA
- 2025-06-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0467-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.