Spirit Sciences USA, Inc. is recalling approximately 382,464 retail units of RU-21 (20 tablets) because the product was marketed as an unapproved new drug. This means the product's safety and effectiveness for its intended use have not been reviewed or verified by the FDA. The affected products were distributed nationwide via the internet in 20-tablet packages with 'U.S. Patent Pending' printed on the label.
The product is being recalled because it was marketed with claims that require FDA approval as a drug; without such review, there is no guarantee of the product's safety, quality, or effectiveness. This lack of regulatory oversight could lead to consumers using an unverified product for health purposes instead of seeking proven treatments.
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
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