One Source Nutrition, Inc, drug recall: Vitality
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96328
- Recall initiated
- Feb 20, 2025
- Classified by FDA
- Mar 17, 2025
- Posted in Enforcement Report
- Mar 26, 2025
- Recalling firm
- One Source Nutrition, Inc,
- Firm location
- Benton, AR, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Feb 20, 2025. FDA classified it 25 days later, on Mar 17, 2025. Distribution reported by FDA: Nationwide in the U.S.A
Recalled products (1)
D-0281-2025 Class I Ongoing
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
Codes / lots: All lots
Quantity: a) 300 individually wrapped capsules b) 20 bottles
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 96328
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.