FDA Recall D-0463-2025

SAINI TRADE INC · Tempe, AZ

Class I — life-threatening Ongoing 395 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

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

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

Quantity: 3000 boxes

Reason for recall

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

Recall record

Recall number: D-0463-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2025-04-14
Classified by FDA Center: 2025-06-11
FDA published: 2025-06-18
Recalling firm: SAINI TRADE INC
Firm location: Tempe, AZ

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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