Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b)...
FDA Recall #D-0281-2025 — Class I — February 20, 2025
Product Description
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
Reason for Recall
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Recalling Firm
One Source Nutrition, Inc, — Benton, AR
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
a) 300 individually wrapped capsules b) 20 bottles
Distribution
Nationwide in the U.S.A
Code Information
All lots
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated