Why it was recalled
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Product description
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide in the U.S.A
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0281-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Feb 20, 2025
- FDA report date
- Mar 26, 2025
- Quantity
- a) 300 individually wrapped capsules b) 20 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- One Source Nutrition, Inc,
Original FDA data
Every field from FDA enforcement report D-0281-2025, exactly as published.
Show all FDA fields
- City
- Benton
- State
- AR
- Status
- Ongoing
- Country
- United States
- Event ID
- 96328
- Address
- 19863 Interstate 30 S
- Code information
- All lots
- Postal code
- 72015-6966
- Report date
- Mar 26, 2025
- Product type
- Drugs
- Recall number
- D-0281-2025
- Classification
- Class I
- Recalling firm
- One Source Nutrition, Inc,
- Product quantity
- a) 300 individually wrapped capsules b) 20 bottles
- Reason for recall
- Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
- Distribution pattern
- Nationwide in the U.S.A
- Recall initiation date
- Feb 20, 2025
- Initial firm notification
- Center classification date
- Mar 17, 2025