February 2025 FDA Recall Drug by One Source Nutrition, Inc,
D-0281-2025 - Marketed without an approved NDA/ANDA

This Class I drug recall was voluntarily initiated by One Source Nutrition, Inc, on February 20, 2025 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0281-2025

Reason for Recall
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Initiated
02-20-2025
Reported
03-26-2025
Quantity
a) 300 individually wrapped capsules b) 20 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96328
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
One Source Nutrition, Inc,
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the U.S.A
Product Description About Product Description
Full technical description of the product.
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.

Batch or Lot Expiration Information

Lot# All lots