Recall notice · FDA Recall Press Releases

Health Fixer: FDA Recall Notice (Apr 29, 2025)

Agency action: Apr 29, 2025Record ID: fda_recall_p-ef6399020956e30e
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What happened

Original notice title

Health Fixer Issues Voluntary Nationwide Recall of Male Ultra, Malextra, Electro Buzz, Ultra Armor and Male Ultra Pro Due to Undeclared Chloropretadalafil, Propoxyphenylsildenafil and…

From the archived source record

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. More Recalls, Market Withdrawals, & Safety Alerts Recalls, Market Withdrawals, & Safety Alerts Recall Resources Enforcement Reports Industry Guidance For Recalls Major Product Recalls FOR IMMEDIATE RELEASE – 04/25/2025 – Tempe, AZ, HEALTH FIXER is voluntarily recalling all lots of dietary supplements by the name of Male Ultra, Malextra, Electro Buzz, Ultra Armor and Male Ultra Pro- blister packs of 10 capsules per box/carton to the consumer level. Laboratory analysis has found the products to be tainted with chloropretadalafil, propoxyphenylsildenafil, and sildenafil. Sildenafil is an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. Chloropretadalafil and propoxyphenylsildenafil are analogues of PDE-5 inhibitors and are likely to carry the same clinical risks. Products containing chloropretadalafil, propoxyphenylsildenafil, and sildenafil cannot be marketed as dietary supplements. These products are unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall Risk Statement: 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. To date, HEALTH FIXER has not received any reports of adverse events related to this recall.

What the official notice says to do

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Status and source details

Status recorded in the archive
Published recall notice
Source checked
Jul 16, 2026
Record revision
9ff1386dae10

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

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What is affected

Product
Male Enhancement Dietary Supplements; 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
Company
Health Fixer
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.