← FDA ENFORCEMENT
D-0464-2025Class I

SAINI TRADE INC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
SAINI TRADE INC
Product type
Drug
Status
Ongoing
Report date
2025-06-18
Distribution
Nationwide
Firm state
AZ
Product quantity
500 boxes
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.

Code / lot info

All lots Lot #: KT-1ST-43-01-04/2026, Exp. 04/25/2026

Data: U.S. FDA. 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. Open the enforcement explorer →