Cholestene Capsules (HPF) – Unapproved Marketing (2021)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
High Performance Formulas, L.L.C. (HPF, L.L.C.)
Lot Codes / Batch Numbers
Lot #30317, exp. date 02/2026
Products Sold
Lot #30317, exp. date 02/2026
High Performance Formulas, L.L.C. (HPF, L.L.C.) is recalling Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: Hi due to Marketed Without an Approved NDA/ANDA. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Marketed Without an Approved NDA/ANDA
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026