CLASS I ONGOING Drug recall · Reported 26 Mar 2025 · FDA Enforcement Report
Vitality, Fast Acting Male Enhancement Product recalled
One Source Nutrition Inc is recalling Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per, distributed nationwide in the US. The recall was initiated on 20 Feb 2025 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0281-2025
- FDA event ID
- 96328
- Recalling firm
- One Source Nutrition Inc, Benton, AR
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 20 Feb 2025
- FDA classified
- 17 Mar 2025
- Reported
- 26 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
Timeline
| 20 Feb 2025 | Recall initiated by company | |
| 17 Mar 2025 | Classified by FDA | +25 days |
| 26 Mar 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Product as listed by the FDA
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
Where it was distributed
Nationwide in the U.S.A
Questions about this recall
Why was it recalled?
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Which lots are affected?
All lots
Where was it sold?
Nationwide in the U.S.A
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.