Class IOngoing

Male Ultra Pro recall

FDA recall D-0467-2025 · initiated Apr 14, 2025

Most serious — a reasonable probability that use will cause serious harm or death.

Why it was recalled

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

Details

Product: Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
Recalling company: SAINI TRADE INC
Classification: Class I
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide
Initiated: Apr 14, 2025
FDA report date: Jun 18, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0467-2025 ↗

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