FDA Drug recall D-0727-2021
Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas, L.L.C. (HPF, L…
- FDA Drug
- Class II
- terminated
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas, L.L.C. (HPF, L… by High Performance Formulas Hpf, citing marketed Without an Approved NDA/ANDA.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0727-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-26 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | High Performance Formulas Hpf |
| Distribution | US |
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
Marketed Without an Approved NDA/ANDA
Identifiers
| upc | 640485100934 |
|---|---|
| code_info | Lot #30317, exp. date 02/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0727-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.