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

Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.

One Source Nutrition, Inc, Published Mar 26, 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 One Source Nutrition, 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: Product found to be tainted with undeclared sildenafil and tadalafil.

Hazards

Undeclared sildenafil · primaryUndeclared tadalafil

Affected products (1)

Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.

a) 300 individually wrapped capsules b) 20 bottles

Code info: All lots

Affected areas

Nationwide

Timeline

  1. Initiated
    Feb 20, 2025
  2. Published
    Mar 26, 2025
Recall number
D-0281-2025
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.