← FDA ENFORCEMENT
D-0467-2025Class 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
300 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 Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.

Code / lot info

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

Other recalls SPEQ maps to Documentation & Change Control
2026-07-22Class IIDaavlin Distributing Company2026-07-22Class IIOrthofix U.S. LLC2026-07-22Class II3B Medical, Inc.2026-07-22Class IIDaavlin Distributing Company
See all Documentation & Change Control recalls →

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.