Male Ultra Pro dietary supplement recalled for undeclared pharmaceutical ingredients
Male Ultra Pro capsules are being recalled because laboratory testing found undeclared propoxyphenylsildenafil and sildenafil. The product was marketed without an approved New Drug Application.
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 as a Class I recall, which per the rubric requires a minimum severity score of 4. The undeclared pharmaceutical ingredients present a serious health risk, particularly to consumers with contraindications to these drugs.
Plain-English summary
Male Ultra Pro, Unleash Your Force 2 (10 capsules per box, UPC B0CZN7C6YH) is being recalled by SAINI TRADE INC due to the presence of undeclared pharmaceutical ingredients. Laboratory analysis found the product to be tainted with propoxyphenylsildenafil and sildenafil, which are not listed on the product label or packaging.
The product was marketed without an FDA-approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), making its distribution illegal. Approximately 300 boxes with Lot # KT-1ST-43-0110/2025 (expiration 03/15/2026) were distributed nationwide by Health Fixer, located in Tempe, Arizona.
Consumers who have purchased this product should stop using it immediately and consult their healthcare provider, especially if they have experienced any adverse effects. The product should be returned to the place of purchase or disposed of safely.
The recalled product
- Product
- Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
- Manufacturer
- SAINI TRADE INC
- Affected units
- 300
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-43-0110/2025
- Exp. 03/15/2026
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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