Dietary Supplement Male Ultra Recalled for Undeclared Drug Ingredients
Male Ultra dietary supplement, distributed nationwide in 3,000 boxes, has been recalled because laboratory testing found it contains undeclared pharmaceutical ingredients: propoxyphenylsildenafil and sildenafil. The product was marketed without FDA approval.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I. The product contains undeclared pharmaceutical ingredients (propoxyphenylsildenafil and sildenafil) in an unapproved drug product marketed as a dietary supplement, posing a potential risk of serious adverse effects including cardiovascular complications. Per the rubric, FDA Class I recalls are never below a score of 4.
Plain-English summary
Male Ultra, Unleash Your Force, a dietary supplement sold in 10-capsule boxes (UPC B0CMQ4FTHG, Lot #KT-1ST-43-01-10-2025, expiration 01/10/2027) distributed nationwide by Health Fixer in Tempe, Arizona, is being recalled. The manufacturer, SAINI TRADE INC, did not obtain FDA approval before marketing the product.
Laboratory analysis found that the product is tainted with two undeclared pharmaceutical ingredients: propoxyphenylsildenafil and sildenafil. These active drug substances were not listed on the product label, and the product was marketed as an unapproved dietary supplement rather than as a drug.
Consumers who have purchased this product should stop using it immediately. Those with questions or concerns should contact their healthcare provider.
The recalled product
- Product
- Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.
- Manufacturer
- SAINI TRADE INC
- Category
- Drug — Dietary Supplement
- Affected units
- 3,000
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-43-01-10-2025
- Exp. 01/10/2027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by SAINI TRADE INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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