Use caution Drug recall · FDA · Published July 26, 2021

Cholestene Red Yeast Rice Recall: Unapproved Drug Hazard

High Performance Formulas recalls Cholestene capsules because they were marketed without an approved New Drug Application. Check your bottle lot and expiration date.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0727-2021Drug Cholestene ›

Use caution until it’s fixed

Marketed Without an Approved NDA/ANDA

Take action

Contact the company

Recalling firmHigh Performance Formulas, L.L.C. (HPF, L.L.C.)2001 Makefield Rd · Yardley, PA 19067-3127

✎ GovInfoNow plain-language explainer

High Performance Formulas, L.L.C. is recalling Cholestene capsules containing red yeast rice because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This means the FDA has not reviewed the product for safety and effectiveness. The recall affects 14,848 bottles distributed nationwide. Read more at govinfonow.com/recall/36060-cholestene-red-yeast-rice-recall-unapproved-drug-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/36060-cholestene-red-yeast-rice-recall-unapproved-drug-hazard · Updated October 10, 2026 · FDA enforcement record: FDA #D-0727-2021

Cite this page

“Cholestene Red Yeast Rice Recall: Unapproved Drug Hazard.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/36060-cholestene-red-yeast-rice-recall-unapproved-drug-hazard. Based on FDA recall #D-0727-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0727-2021%22&limit=1).

The Food and Drug Administration announced on July 26, 2021, that High Performance Formulas, L.L.C. is recalling Cholestene capsules because they are marketed without an approved New Drug Application or Abbreviated New Drug Application.

How to tell if you have it

Brand: Cholestene
Product: Cholestene Red Yeast Rice Capsules
UPC: 00640485100934
Lot #: 30317
Expiration date: 02/2026

The hazard

The product is classified as a Class II recall because it is marketed without an approved New Drug Application or Abbreviated New Drug Application.

Context

GovInfoNow's records show other recent recalls of similar products include Xiamen Kang Zhongyuan Cherry Cough Drops Recall (2026-03-20) and Xyvona (Levorphanol) 2mg Tablet Recall (2026-05-22). Additional related actions include the Xiamen Kang Zhongyuan Biotechnology Cough Drops Recall reported on 2026-03-20.

How to tell if you have this one

Look for a 120-count bottle of Cholestene capsules manufactured by High Performance Formulas, L.L.C. The UPC code is 640485-10093-4. Check the label for Lot #30317 and an expiration date of 02/2026.

Brand
Cholestene
Product
Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop taking the supplement
Discontinue use of the recalled Cholestene capsules immediately as they are not FDA-approved.
Check your bottle details
Verify if your bottle matches UPC 640485-10093-4, Lot #30317, and expires in 02/2026.
Contact the manufacturer
Reach out to High Performance Formulas, L.L.C. at P.O. Box 1311, Morrisville, PA 19067 for further instructions.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Product was distributed nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

Jul 26, 2021Firm started the recall
Aug 15, 2021FDA classified it Class II
Aug 25, 2021Published in FDA’s Enforcement Report
May 4, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/36060-cholestene-red-yeast-rice-recall-unapproved-drug-hazard">Cholestene Red Yeast Rice Recall: Unapproved Drug Hazard (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0727-2021 (July 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0727-2021 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.