Dietary Supplement MALEXTRA Recalled for Undeclared Drug Contamination
MALEXTRA, a dietary supplement distributed nationwide, was recalled because laboratory analysis found it contaminated with undeclared pharmaceutical ingredients: propoxyphenylsildenafil and sildenafil. The product was marketed without required FDA approval.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, which the severity rubric designates as Critical. The product was contaminated with undeclared pharmaceutical ingredients and marketed without required FDA approval.
Plain-English summary
MALEXTRA, Recharge with Extra, is a dietary supplement in boxes of 10 capsules. It was distributed nationwide by Health Fixer (Tempe, AZ 85288) and manufactured by SAINI TRADE INC. The affected lot is KT-1ST-43-01-04/2026, with an expiration date of 04/25/2026. Approximately 500 boxes were distributed.
The FDA issued a Class I recall after laboratory analysis found the product contaminated with two undeclared pharmaceutical ingredients: propoxyphenylsildenafil and sildenafil. The product was marketed without the required FDA approval (New Drug Application or Abbreviated New Drug Application).
Consumers who have purchased MALEXTRA should stop using the product immediately. Check the lot number (KT-1ST-43-01-04/2026) and expiration date (04/25/2026) on your package. If you have taken this product and experience any adverse effects, contact a healthcare provider.
The recalled product
- Product
- MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.
- Manufacturer
- SAINI TRADE INC
- Category
- Drug — Dietary Supplement
- Hazard
- undeclared-drugs
- sildenafil
- propoxyphenylsildenafil
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All lots Lot #: KT-1ST-43-01-04/2026
- Exp. 04/25/2026
Distribution
Distributed nationwide across the United States.
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