Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class I · High risk Ongoing Initiated Apr 14, 2025 (1 years ago)

Male Ultra Pro

Class I — High risk. Reasonable probability of 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.

Cause type: Chemical / undeclared

A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.

What was recalled

Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.

Recalling firm
Saini Trade INC
Origin
AZ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0467-2025 · FDA notice

Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.

Other recalls by Saini Trade INC

All 2025 recalls
Class I · High risk

Ultra Armor

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

Ongoing Chemical / undeclared Saini Trade INC D-0466-2025
Class I · High risk

Electro Buzz

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

Ongoing Chemical / undeclared Saini Trade INC D-0465-2025
Class I · High risk

Malextra

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

Ongoing Chemical / undeclared Saini Trade INC D-0464-2025
Class I · High risk

Male Ultra

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

Ongoing Chemical / undeclared Saini Trade INC D-0463-2025

Other chemical / undeclared recalls from 2025

All chemical / undeclared recalls
Class I · High risk

SILINTAN 25/pills

Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.

Ongoing Chemical / undeclared ANTHONY TRINH, 123Herbals LLC D-0388-2026