Cholestene capsules — Class II drug recall D-0727-2021
Terminated recall by High Performance Formulas, L.L.C. (HPF, L.L.C.), reported 2021-08-25, distributed nationwide. Marketed Without an Approved NDA/ANDA
| Recall number | D-0727-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | High Performance Formulas, L.L.C. (HPF, L.L.C.), Yardley, PA, United States |
| Recall initiated | 2021-07-26 |
| Classified | 2021-08-15 |
| Reported by FDA | 2021-08-25 |
| Terminated | 2023-05-04 |
| Distributed | Nationwide (US) |
| Quantity | 14,848 bottles |
| Reason classes | unapproved product |
| Lot numbers | 30317 |
| Expiration dates | 2026-02 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0727-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.