D-0281-2025 Class I Ongoing
FDA drug recall D-0281-2025 was initiated by One Source Nutrition, Inc, on February 20, 2025 and is designated Class I. Reason for recall: Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil. The recall status is ongoing. Affected quantity: a) 300 individually wrapped capsules b) 20 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 26, 2025
- Initiation Date
- February 20, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 300 individually wrapped capsules b) 20 bottles
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.
Distribution Pattern
Nationwide in the U.S.A
Code Information
All lots