Dietary supplements sold on Amazon recalled over undeclared, potentially harmful ingredients
One of the recalled dietary supplements, called Malextra, is pictured in a provided image. (Credit: U.S. Food and Drug Administration)
TEMPE, Ariz. - Several male enhancement dietary supplements have been recalled due to undeclared and potentially harmful ingredients being detected, U.S. health officials said.
The recall notice, published by the U.S. Food and Drug Administration on April 29, states that the products were sold nationwide on Amazon.
Here’s what to know:
Male enhancement dietary supplements recalled
What we know:
Health Fixer has voluntarily recalled all lots of dietary supplements by the names of Male Ultra, Malextra, Electro Buzz, Ultra Armor and Male Ultra Pro. A laboratory analysis found the products were 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. The FDA notice said that 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, the notice warned. These products are unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall.
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Why you should care:
The FDA recall notice states that 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 could be life-threatening. Those with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Dig deeper:
Health Fixer’s supplements were distributed nationwide via Amazon. To date, Health Fixer said it has not received any reports of adverse events related to the recall. They were sold in blister packs of 10 capsules per box with the following codes, according to the FDA notice:
- Male Ultra - NDC/UPC: B0CMQ4FTHG, KT-1ST-43-0110-2025, Expiration 01/10/2027
- Malextra - NDC/UPC: B0CWKZ6ZP3, KT-1ST-43-0104/2026, Expiration 04/25/2026
- Electro Buzz - NDC/UPC: B0DK68LF6J, KT-1ST-43-0107/2024, Expiration 10/15/2026
- Ultra Armor - NDC/UPC: B0CYJ7Y5H9, KT-1ST-43-0110/2025, Expiration 01/10/2027
- Male Ultra Pro - NDC/UPC: B0CZN7C6YH, KT-1ST-43-0110/2025, Expiration 03/15/2026
Click here to view the product photos.
What they're saying:
"Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product," the FDA notice said.
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What's next:
Health Fixer is notifying its distributors and customers of all recalled products.
What you can do:
Consumers are being asked to immediately stop using the recalled products. Anyone with questions can contact Health Fixer at (414) 888-8818 or email [email protected] from Monday to Friday 9 a.m.- 6 p.m. MT.
Adverse reactions or quality problems after use of a recalled product can be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
The Source: This story was written based on information published by the U.S. Food and Drug Administration regarding the recall on April 29, 2025. It was reported from Cincinnati.