FDAClass IIAugust 25, 2021

Cholestene capsules recall

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.…

Why was Cholestene capsules recalled?

Marketed Without an Approved NDA/ANDA

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #30317, exp. date 02/2026

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.…
Recalling firm
High Performance Formulas, L.L.C. (HPF, L.L.C.)
Quantity
14,848 bottles
Distribution
Product was distributed nationwide.
Recall date
August 25, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls