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Drug FDA Class I Ongoing Mislabeling

ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.

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)

ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.

500 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-0466-2025
Agency
U.S. Food and Drug Administration
Country
US

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.