High Performance Formulas (HPF, L.L.C.) is recalling 14,848 bottles of Cholestene capsules, a red yeast rice dietary supplement. The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), meaning its safety and effectiveness for its intended use have not been officially reviewed by the FDA. Consumers should check their supply for 120-count bottles of Cholestene (1200 mg per 2 capsules) with Lot #30317 and an expiration date of 02/2026. If you have this product, you should contact your healthcare provider or pharmacist regarding its use.
The product is being marketed as a drug without the required FDA approval, which means the agency has not verified the manufacturer's claims regarding safety, quality, or efficacy. Using unapproved medications can pose a risk to health because they have not undergone the rigorous testing required for legal sale.
Healthcare consultation and potential 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.