Boulla LLC 2024-12-11 Health critical FDA
Health · FDA · Recall #FDA-D-0083-2025
VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by:… Recall
Issued December 11, 2024 · Boulla LLC
In December 2024, Boulla LLC recalled the VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by:…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
What you should do
- 1 Stop using VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by:… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Boulla LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Boulla LLC
- Category
- Health
- Recall date
- December 11, 2024
- Units affected
- Not reported
- Sold at
- Nationwide within the United States
- Recall number
- FDA-D-0083-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Boulla LLC has 2 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.