Fusion Health Immune Boost Recalled for Marketing Without FDA Approval
Fusion Health and Vitality LLC is recalling 5,000 bottles of Immune Boost because the product was marketed with drug claims without an approved NDA or ANDA.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The specific issue is regulatory (marketing without approval) rather than a direct physical hazard like contamination or injury, fitting the Moderate severity criteria for labeling/regulatory errors.
Plain-English summary
Fusion Health and Vitality LLC is recalling 5,000 bottles of Immune Boost with natural strawberry flavor, 8,000 IU. The product is a 60 mL bottle manufactured by Fusion Health and Vitality, LLC, located in Alpharetta, Georgia.
The recall was initiated because the product was marketed with drug claims without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This means the product was distributed as a drug without the necessary regulatory approval from the FDA.
The affected lots are 200407, 200413, 200420, 200602, and 200608. The product was distributed nationwide in the U.S. Consumers should stop using the product and contact the manufacturer for instructions on how to return it or obtain a refund.
The recalled product
- 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.
- Manufacturer
- Fusion Health and Vitality LLC
- Category
- Drug — Supplement
- Hazard
- Affected units
- 5,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #s: 200407
- 200413
- 200420
- 200602
- 200608.
Distribution
Distributed nationwide across the United States.
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