Health Fixer has voluntarily recalled all lots of its male enhancement dietary supplements, Male Ultra, Malextra, Electro Buzz, Ultra Armor, and Male Ultra Pro, after laboratory analyses detected the presence of undeclared prescription drugs.
The U.S. Food and Drug Administration (FDA) announced that these products contain sildenafil, chloropretadalafil, and propoxyphenylsildenafil. Sildenafil is an active ingredient in FDA-approved medications for erectile dysfunction. Chloropretadalafil and propoxyphenylsildenafil are structurally similar to sildenafil and are likely to pose similar health risks. These substances are not declared on the product labels, rendering the supplements unapproved new drugs.
The presence of these undeclared ingredients can lead to serious health consequences. Specifically, sildenafil and its analogs can interact with nitrates found in some prescription medications, such as nitroglycerin, leading to a significant drop in blood pressure. This interaction can be life-threatening, particularly for individuals with diabetes, high blood pressure, high cholesterol, or heart disease, who often take nitrates.
The affected products were sold nationwide in the United States through Amazon. They were packaged in blister packs containing 10 capsules per box. The specific products and their associated codes are as follows:
- Male Ultra: NDC/UPC B0CMQ4FTHG, Lot KT-1ST-43-0110-2025, Expiration 01/10/2027
- Malextra: NDC/UPC B0CWKZ6ZP3, Lot KT-1ST-43-0104/2026, Expiration 04/25/2026
- Electro Buzz: NDC/UPC B0DK68LF6J, Lot KT-1ST-43-0107/2024, Expiration 10/15/2026
- Ultra Armor: NDC/UPC B0CYJ7Y5H9, Lot KT-1ST-43-0110/2025, Expiration 01/10/2027
- Male Ultra Pro: NDC/UPC B0CZN7C6YH, Lot KT-1ST-43-0110/2025, Expiration 03/15/2026
As of the announcement date, Health Fixer has not received any reports of adverse events related to these products. However, consumers are advised to stop using these supplements immediately and consult a healthcare provider if they have experienced any problems that may be related to taking or using these products.
Consumers with questions regarding this recall can contact Health Fixer at (414) 888-8818 or via email at [email protected], Monday through Friday, 9 a.m. to 6 p.m. Mountain Time.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm
- Download the form 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-0178adverse events to help the FDA monitor the safety of products on the market.
