Fusion Health and Vitality LLC recalls Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced Immune System, 60 mL bottle,
Fusion Health recalls Immune Boost with natural strawberry flavor due to being marketed with drug claims without FDA approval. Consumers should check lot numbers 200407-200608 for affected products.
Recall notice
Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
Contact the company & request your remedy
What happened, in plain English
Fusion Health is recalling a vitamin supplement labeled as an immune booster because it was marketed with drug claims without FDA approval. This means the product may not be safe for use as a medication. Read more at govinfonow.com/recall/36667-fusion-health-immune-boost-recall-product-marketed-without-fda-approval.
Source Summary by GovInfoNow · govinfonow.com/recall/36667-fusion-health-immune-boost-recall-product-marketed-without-fda-approval · Updated October 4, 2026 · FDA enforcement record: FDA #D-0107-2021
Cite this page
“Fusion Health Immune Boost Recall: Product Marketed Without FDA Approval.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36667-fusion-health-immune-boost-recall-product-marketed-without-fda-approval. Based on FDA recall #D-0107-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0107-2021%22&limit=1).
Why it’s dangerous
The product was marketed as a drug (with immune-boosting claims) without receiving FDA approval. This means it could be unsafe for medical use, as the FDA requires approval for such claims.
Who’s affected
People who purchased the Immune Boost supplement with lot numbers 200407, 200413, 200420, 200602, or 200608 are affected. Those using the product for medical purposes are at higher risk.
How to tell if you have this one
Check the lot number on the bottle, which is one of 200407, 200413, 200420, 200602, or 200608. The product is a 60 mL bottle with natural strawberry flavor and 8,000 IU.
- Brand
Fusion Health- Category
Drug
What to do — step by step
Check Product Lot Number
Look for the lot number on the bottle, which should be one of 200407, 200413, 200420, 200602, or 200608.
Questions people ask
Is this product safe to use?
The product was marketed with drug claims without FDA approval, so it may not be safe for medical use. The official recall does not specify if it's safe for general health purposes.
What should I do if I have this product?
The recall does not provide specific action steps beyond checking the lot number. Consumers should contact Fusion Health directly for further guidance.
How can I confirm if my product is affected?
Check the lot number on the bottle; affected products have lot numbers 200407, 200413, 200420, 200602, or 200608.
Contact Fusion Health
We’ve drafted a message you can send Fusion Health to request your refund or repair — edit it as you like.
Subject: Recall D-0107-2021 — Fusion Health Fusion Health Hello, I own a Fusion Health that is covered by recall D-0107-2021 from Fusion Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0107-2021 (November 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0107-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.