Fusion Health and Vitality LLC is recalling approximately 5,000 bottles of Immune Boost with natural strawberry flavor (8,000 IU). This product was marketed with drug claims that have not been approved by the FDA, meaning it has not been evaluated for safety or effectiveness for its advertised uses. Consumers should contact their healthcare provider or pharmacist regarding the use of this product and return any unused portions to the place of purchase for a refund.
The product is being sold without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), posing a risk because the manufacturing process, quality controls, and safety of the drug claims have not been verified by federal regulators.
Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.