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).
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.)
- Affected units
- 14,848
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.
Related recalls
Same hazard · unapproved drug marketing
See all →- HighInfant Probiotic Supplement Recall: Abbott Similac Tri-Blend Unsafe Additive
FDA (Food) · 2023-11-15
Other drug recalls
- ModerateFei Fah Recalls Electric Medicated Balm Due to Manufacturing Deviations
FDA (Drugs) · 2026-11-04
- ModerateABC Compounding Recalls Chemseptic Due to Manufacturing Deviations
FDA (Drugs) · 2026-11-04
- SevereAtorvastatin Calcium Tablets Recalled for Presence of Foreign Tablets or Capsules
FDA (Drugs) · 2026-11-04
- ModerateABC Compounding Recalls Wechem Hand Guard Bags Due to CGMP Deviations
FDA (Drugs) · 2026-11-04
- LowMeitheal Pharmaceuticals Recalls Vecuronium Bromide Injection for Labeling Defect
FDA (Drugs) · 2026-11-04
Similar recalls
- SevereRed Yeast Rice Supplement Recalled for Excessive Lovastatin Levels
FDA (Drugs) · 2014-05-28
- SevereFDA Recalls Ultra-Sten Capsules Marketed Without Approval
FDA (Drugs) · 2017-08-23
- SevereDoctor's Best Red Yeast Rice Recalled for Undeclared Lovastatin
FDA (Drugs) · 2014-08-27
- ModerateUnapproved Aniracetam and Choline Capsules Recalled by FDA
FDA (Drugs) · 2013-04-10
- ModeratePalmer Natural Products Recalls Unapproved Oxiracetam and Choline Capsules
FDA (Drugs) · 2013-04-10
- HighDuloxetine Drug Recall Due to Manufacturing Impurity Levels
FDA (Drugs) · 2025-01-15