FDA recall D-0465-2025

SAINI TRADE INC · Class I · drug

Product

ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-04-14
Report date: 2025-06-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0465-2025