Elevated risk U.S. Food and Drug Administration

Health Fixer Male Enhancement Dietary Supplements recall: Undeclared Chloropretadalafil, Propoxyphenylsildenafil, Sildenafil

Recall published 1+ years ago

Undeclared Chloropretadalafil, Propoxyphenylsildenafil, Sildenafil

Health Fixer Dietary supplements — recalled dietary supplementsHealth Fixer Dietary supplements — recalled dietary supplements (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

This is a labelling recall rather than a contamination one: something that must be declared is in the product and is not on the label.

What the notice says: 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.

Why it matters: An ingredient that U.S. law requires to be declared is present but missing from the label. People who avoid that ingredient cannot make a safe choice from the packaging.

Symptoms and when to call a doctor

An undeclared allergen is a danger only to people allergic or intolerant to that ingredient. For everyone else the food is safe. Reactions range from an itchy mouth, hives, stomach cramps or vomiting through to anaphylaxis — swelling of the lips, tongue or throat, a tight chest, wheezing, a sudden drop in blood pressure or collapse. If anaphylaxis is suspected, use an epinephrine auto-injector straight away and call 911, even if the symptoms seem to settle, because a second wave can follow hours later.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
April 25, 2025
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Health Fixer
Product type
Dietary supplements
Distribution
Nationwide
Sold at
Amazon

Products covered by this recall

Male Enhancement Dietary Supplements

What the company announced

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 <enter how each product is packaged here>.

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: Male Ultra · NDC/UPC: B0CMQ4FTHG · Lot Numbers: KT-1ST-43-0110-2025 · Expiration: 01/10/2027
  • Product Name: Malextra · NDC/UPC: B0CWKZ6ZP3 · Lot Numbers: KT-1ST-43-0104/2026 · Expiration: 04/25/2026
  • Product Name: Electro Buzz · NDC/UPC: B0DK68LF6J · Lot Numbers: KT-1ST-43-0107/2024 · Expiration: 10/15/2026
  • Product Name: Ultra Armor · NDC/UPC: B0CYJ7Y5H9 · Lot Numbers: KT-1ST-43-0110/2025 · Expiration: 01/10/2027
  • Product Name: Male Ultra Pro · NDC/UPC: B0CZN7C6YH · Lot Numbers: KT-1ST-43-0110/2025 · Expiration: 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 [email protected] 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.

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

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • KT-1ST-43-0110-2025
  • KT-1ST-43-0104/2026
  • KT-1ST-43-0107/2024
  • KT-1ST-43-0110/2025

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 01/10/2027
  • 04/25/2026
  • 10/15/2026
  • 03/15/2026

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Allergen

Health Fixer — This is a labelling recall rather than a contamination one: something that must be declared is in the product and is not on the label.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. Warn anyone else who eats from your kitchen, including schools and childminders.
  3. Report any reaction to the FDA so it is recorded against this recall.
  4. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

Remedy named in the notice: 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.

Company contact: Health Fixer — Consumers: Health Fixer, 414-888-8818, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Health Fixer dietary supplements recalled?

Undeclared Chloropretadalafil, Propoxyphenylsildenafil, Sildenafil 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code KT-1ST-43-0110-2025, KT-1ST-43-0104/2026, KT-1ST-43-0107/2024; best-by date 01/10/2027 or 04/25/2026. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.

Can I get my money back?

The notice says: 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.

Where was the recalled product sold?

It was distributed nationwide, including at Amazon.

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