FDA

Male enhancement supplements recalled due to undeclared drugs

May 6, 2025

Health Fixer has issued a voluntary nationwide recall of several male enhancement dietary supplements, including Male Ultra, Malextra, Electro Buzz, Ultra Armor, and Male Ultra Pro. Laboratory analysis revealed these products contain undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil. These substances are analogues of phosphodiesterase (PDE-5) inhibitors, commonly used to treat erectile dysfunction, and are not approved for use in dietary supplements. The affected products were distributed nationwide via Amazon and other retailers.

Consumption of products with undeclared PDE-5 interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.

Physicians should advise patients to discontinue use of these products immediately and report any adverse reactions.

Source:

(2025, April 29). FDA. Health Fixer Issues Voluntary Nationwide Recall of Male Ultra, Malextra, Electro Buzz, Ultra Armor and Male Ultra Pro Due to Undeclared Chloropretadalafil, Propoxyphenylsildenafil and Sildenafil. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/health-fixer-issues-voluntary-nationwide-recall-male-ultra-malextra-electro-buzz-ultra-armor-and