FDA recall D-0281-2025

One Source Nutrition, Inc, · Class I · drug

Product

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

Nationwide in the U.S.A

Key facts

Status
Ongoing
Initiation date
2025-02-20
Report date
2025-03-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Benton, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0281-2025