Cholestene Capsules Recalled for Marketing Without Approved Application
High Performance Formulas is recalling Cholestene capsules (red yeast rice supplement, 1200 mg per 2 capsules, 120-count bottles) because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
What this means for you
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 source identifies this as an FDA Class II recall, and no illnesses, injuries, or hospitalization reports are mentioned. The hazard is regulatory non-compliance (unapproved marketing status) without evidence of actual product contamination or harm, making this a moderate-severity precautionary action.
Plain-English summary
High Performance Formulas, L.L.C. is recalling Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle (UPC 640485-10093-4, Lot #30317, expiration date 02/2026). A total of 14,848 bottles were affected. The product was distributed nationwide.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), in violation of federal law. Products marketed as drugs must obtain FDA approval before distribution.
Consumers who have purchased this product should stop using it and contact High Performance Formulas or consult a healthcare provider with questions about its use.
The recalled product
- Product
- Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas, L.L.C. (HPF, L.L.C.) P.O. Box 1311, Morrisville, PA 19067, UPC 640485-10093-4
- Manufacturer
- High Performance Formulas, L.L.C. (HPF, L.L.C.)
- Hazard
- unapproved-drug-marketing
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 (2)
- Lot #30317
- exp. date 02/2026
Distribution
Distributed nationwide across the United States.
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