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

FDA recall notice · announced August 25, 2021 · High Performance Formulas, L.l.c. (hpf, L.l.c.)

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Marketed Without an Approved NDA/ANDA

Notes

Distribution: Product was distributed nationwide.
Lot/code information: Lot #30317, exp. date 02/2026
Quantity: 14,848 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0727-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.