# FDA recall D-0727-2021

> **High Performance Formulas, L.L.C. (HPF, L.L.C.)** · Class II · drug recall initiated 2021-07-26.

## 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

## Distribution

Product was distributed nationwide.

## Key facts

- **Recall number:** D-0727-2021
- **Recalling firm:** High Performance Formulas, L.L.C. (HPF, L.L.C.)
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-07-26
- **Report date:** 2021-08-25
- **Termination date:** 2023-05-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Yardley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0727-2021

## Citation

> AI Analytics. FDA recall D-0727-2021. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0727-2021. Source: US FDA. Licensed CC0.

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