Summary
- Company Announcement Date:
- April 25, 2025
- FDA Publish Date:
- April 29, 2025
- Product Type:
- Dietary Supplements
- Reason for Announcement:
-
Recall Reason Description
Undeclared Chloropretadalafil, Propoxyphenylsildenafil, Sildenafil
- Company Name:
- Health Fixer
- Brand Name:
-
Brand Name(s)
Health Fixer
- Product Description:
-
Product Description
Male Enhancement Dietary Supplements
Company Announcement
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.
The tainted capsules are marketed as dietary supplements used as male enhancement products and are packaged in .
The products are used as an oral supplement and are packaged in blister packs containing 10 units of capsules, with the associated codes as follows:
Product Name |
NDC/UPC |
Lot Numbers |
Expiration |
---|---|---|---|
Male Ultra |
B0CMQ4FTHG |
KT-1ST-43-0110-2025 |
01/10/2027 |
Malextra |
B0CWKZ6ZP3 |
KT-1ST-43-0104/2026 |
04/25/2026 |
Electro Buzz |
B0DK68LF6J |
KT-1ST-43-0107/2024 |
10/15/2026 |
Ultra Armor |
B0CYJ7Y5H9 |
KT-1ST-43-0110/2025 |
01/10/2027 |
Male Ultra Pro |
B0CZN7C6YH |
KT-1ST-43-0110/2025 |
03/15/2026 |
Health Fixer’s supplements were distributed Nationwide across the U.S to Amazon Online Shopping.
HEALTH FIXER is notifying its distributors and customers by this press release of all Health Fixer’s recalled products. Consumers that have any Health Fixer dietary supplements which is being recalled should immediately stop using, discard any of the supplements and may contact their doctor in case of any health risk.
Consumers with questions regarding this recall can contact Health Fixer by the following number (414-888-8818) or e-mail ultrahelpbyfixer@gmail.com from Monday to Friday 9a.m. – 6p.m. Mountain time zone.
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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Company Contact Information
Product Photos
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