← FDA ENFORCEMENT
D-0463-2025Class I

SAINI TRADE INC

Recalling firm
SAINI TRADE INC
Product type
Drug
Status
Ongoing
Report date
2025-06-18
Distribution
Nationwide
Firm state
AZ
Product quantity
3000 boxes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

Product description

Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.

Code / lot info

All Lots Lot #: KT-1ST-43-01-10-2025, Exp. 01/10/2027

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.