VitalityXtra Capsules recalled over undeclared sildenafil
- Recall date
- November 4, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Boulla LLC recalls VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, C…
- Recall number
- D-0083-2025
- FDA classification
- Class I
- Brand / firm
- Boulla LLC
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com
Get recall alerts
Free email alert whenever Boulla LLC has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Boulla LLC