Skip to content
Back to recalls
Drug FDA Class I Ongoing Mislabeling

Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.

SAINI TRADE INC Published Jun 18, 2025

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact SAINI TRADE INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.

Hazards

Undeclared sildenafil · primaryUndeclared propoxyphenylsildenafil

Affected products (1)

Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.

3000 boxes

Lot codes: Lot
Code info: All Lots Lot #: KT-1ST-43-01-10-2025, Exp. 01/10/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 14, 2025
  2. Published
    Jun 18, 2025
Recall number
D-0463-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.