VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: Vitality...
FDA Recall #D-0083-2025 — Class I — November 4, 2024
Product Description
VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com
Reason for Recall
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Recalling Firm
Boulla LLC — Sacramento, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
Unknown
Distribution
Nationwide within the United States
Code Information
Lot #: 230811, Exp: 08/11/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated