CLASS II Drug recall · Reported 2 Dec 2020 · FDA Enforcement Report
Immune Boost with natural strawberry flavor, 8,000 IU recalled
Fusion Health and Vitality is recalling Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced, distributed nationwide in the US. The recall was initiated on 18 Nov 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0107-2021
- FDA event ID
- 86834
- Recalling firm
- Fusion Health and Vitality, Alpharetta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Nov 2020
- FDA classified
- 25 Nov 2020
- Reported
- 2 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 18 Nov 2020 | Recall initiated by company | |
| 25 Nov 2020 | Classified by FDA | +7 days |
| 2 Dec 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
Which lots are affected?
Lot #s: 200407, 200413, 200420, 200602, 200608.
Where was it sold?
Nationwide in the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fusion Health and Vitality
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS II | Pharmorigins Core with Natural Orange Flavor Natural Energy recalledPharmorigins Core | Fusion Health and Vitality | Other | Nationwide |