Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cholestene capsules Recalled by High Performance Formulas, L.L.C. (HPF, L.L.C.) Due to Marketed Without an Approved NDA/ANDA
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact High Performance Formulas, L.L.C. (HPF, L.L.C.) directly.
Affected Products
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
Quantity: 14,848 bottles
Why Was This Recalled?
Marketed Without an Approved NDA/ANDA
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About High Performance Formulas, L.L.C. (HPF, L.L.C.)
High Performance Formulas, L.L.C. (HPF, L.L.C.) has 1 total recall tracked by RecallDetector.
Related Recalls
Icosapent Ethyl Capsules Recalled by Zydus Pharmaceuticals (USA) Inc Due to Failed Tablet/Capsule specifications: Red dots inside capsule and...
Zydus Pharmaceuticals (USA) Inc · March 9, 2026
Product label: Temozolomide Capsules Recalled by Rising Pharma Holding, Inc. Due to Failed Impurities/Degradation Specifications: An out-of-specification result observed during...
Rising Pharma Holding, Inc. · March 3, 2026
Semaglutide Inj. Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Tirzepatide Inj Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Tirzepatide Inj Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report