CLASS II Drug recall · Reported 25 Aug 2021 · FDA Enforcement Report
Cholestene capsules, 1200 mg of red yeast rice recalled
High Performance Formulas, L.L.C. (HPF, L.L.C.) is recalling Cholestene capsules, 1200 mg of red yeast rice per, distributed nationwide in the US. The recall was initiated on 26 Jul 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0727-2021
- FDA event ID
- 88310
- Recalling firm
- High Performance Formulas, L.L.C. (HPF, L.L.C.), Yardley, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jul 2021
- FDA classified
- 15 Aug 2021
- Reported
- 25 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Mold
Timeline
| 26 Jul 2021 | Recall initiated by company | |
| 15 Aug 2021 | Classified by FDA | +20 days |
| 25 Aug 2021 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed Without an Approved NDA/ANDA
Product as listed by the FDA
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
Where it was distributed
Product was distributed nationwide.
Questions about this recall
Is Cholestene capsules, 1200 mg of red yeast rice per recalled?
Yes. High Performance Formulas, L.L.C. (HPF, L.L.C.) recalled Cholestene capsules, 1200 mg of red yeast rice per on 26 Jul 2021. The recall is Class II and its status is Terminated. Recall number D-0727-2021.
Why was it recalled?
Marketed Without an Approved NDA/ANDA
Which lots are affected?
Lot #30317, exp. date 02/2026
Where was it sold?
Product was distributed nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.