Doctor's Best Red Yeast Rice 1200 — Class II drug recall D-1549-2014
Terminated recall by Doctor's Best, Inc., reported 2014-08-27, distributed nationwide. Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapprove
| Recall number | D-1549-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Doctor's Best, Inc., San Clemente, CA, United States |
| Recall initiated | 2014-06-24 |
| Classified | 2014-08-20 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2014-10-21 |
| Distributed | Nationwide (US) |
| Quantity | 7,379 bottles |
| Reason classes | undeclared allergen, unapproved product |
| UPC / GTIN / UDI-DI | 00753950001183 |
| Lot numbers | 02/17, 3121005 |
Product
Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for Doctor's Best San Clemente, CA 92673
Reason for recall
Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.
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-1549-2014. 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.