Red Yeast Rice High Potency Dietary Supplement — Class II drug recall D-1349-2014
Terminated recall by Independent Nutrition Center, Inc., reported 2014-05-28, distributed nationwide. Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovast
| Recall number | D-1349-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Independent Nutrition Center, Inc., Eugene, OR, United States |
| Recall initiated | 2014-04-29 |
| Classified | 2014-05-22 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2014-07-24 |
| Distributed | Nationwide (US) |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00801650022059, 00801650022066 |
| Lot numbers | 1308009, 1309017, 1312008, 1402009 |
Product
Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8 01650 02205 9) and b) 500-count VegeCaps per bottle (UPC 8 01650 02206 6), Manufactured by: Back to Health, Eugene, Oregon 97402.
Reason for recall
Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement 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-1349-2014. 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.