Immune Boost with natural strawberry flavor — Class II drug recall D-0107-2021
Terminated recall by Fusion Health and Vitality LLC, reported 2020-12-02, distributed nationwide. Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
| Recall number | D-0107-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fusion Health and Vitality LLC, Alpharetta, GA, United States |
| Recall initiated | 2020-11-18 |
| Classified | 2020-11-25 |
| Reported by FDA | 2020-12-02 |
| Terminated | 2023-06-02 |
| Distributed | Nationwide (US) |
| Quantity | 5,000 bottles |
| Reason classes | unapproved product |
| Lot numbers | 200407, 200413, 200420, 200602, 200608 |
Product
Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced Immune System, 60 mL bottle, Manufactured by: Fusion Health and Vitality, LLC. 1360 Union Hill Road, Suite 11B Alpharetta, GA 30004.
Reason for recall
Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
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-0107-2021. 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.