FDA Drugs recall ·
VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0083-2025
- Date
- (initiated November 4, 2024)
- Company / brand
- Boulla LLC
2108 N ST #7929, Sacramento, CA, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- Unknown
- Hazard tags
- Undeclared allergen
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com
Why was it recalled?
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 230811, Exp: 08/11/2025
Distribution
Nationwide within the United States
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0083-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.