VitalityXtra Capsules — Class I drug recall D-0083-2025
Ongoing recall by Boulla LLC, reported 2024-12-11, distributed nationwide. Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
| Recall number | D-0083-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boulla LLC, Sacramento, CA, United States |
| Recall initiated | 2024-11-04 |
| Classified | 2024-12-02 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Reason classes | undeclared allergen, unapproved product |
| Lot numbers | 230811 |
| Expiration dates | 2025-08-11 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0083-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.