CLASS II Drug recall · Reported 28 May 2014 · FDA Enforcement Report
Red Yeast Rice High Potency Dietary Supplement, 600 mg recalled
Independent Nutrition Center is recalling Red Yeast Rice High Potency Dietary Supplement, 600 mg, distributed nationwide in the US. The recall was initiated on 29 Apr 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1349-2014
- FDA event ID
- 68199
- Recalling firm
- Independent Nutrition Center, Eugene, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Apr 2014
- FDA classified
- 22 May 2014
- Reported
- 28 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Hidden Drug Ingredients
Timeline
| 29 Apr 2014 | Recall initiated by company | |
| 22 May 2014 | Classified by FDA | +23 days |
| 28 May 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: 1402009; 1312008; 1309017; and 1308009
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.