Dietary supplements recalled because they contain prescription drugs

• Health Fixer is recalling all lots of five male enhancement dietary supplements (Male Ultra, Malextra, Electro Buzz, Ultra Armor, and Male Ultra Pro) due to the presence of undeclared and potentially harmful pharmaceutical ingredients. 

• These ingredients, associated with FDA-approved erectile dysfunction treatments, pose serious health risks.

• Affected products were sold on Amazon and packaged in 10-capsule blister packs.

HEALTH FIXER is 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 said it 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. 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:

What to do

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 who have any Health Fixer dietary supplements which are 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 at the following number (414-888-8818) or e-mail ultrahelpbyfixer@gmail.com from Monday to Friday 9 a.m. - 6 p.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.

Complete and submit the eport 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.