Drug & medication recalls High risk

MALEXTRA recalled over undeclared propoxyphenylsildenafil

Recall date
April 14, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
SAINI TRADE INC recalls MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288,…
Recall number
D-0464-2025
FDA classification
Class I
Brand / firm
SAINI TRADE INC
Sold / distributed
Nationwide

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

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