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Recall Observatory FDA recall evidence

Drug product

Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.

D-0467-2025

April 14, 2025

Class I

Product summary

Firm
SAINI TRADE INC
Event
Event 96735
Status
Ongoing
Classification
Class I
Quantity
300 boxes
Official record key
drug-enforcement:D-0467-2025

Official wording

Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.

Code information: All lots Lot #: KT-1ST-43-0110/2025, Exp. 03/15/2026

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.