June 24, 2014

Doctor's Best Recalls Red Yeast Rice Due to Undeclared Lovastatin

The Missouri Department of Health and Senior Services received information regarding a recall of Red Yeast Rice dietary supplement, 600 mg Capsules, 120-count bottles to the retail level. Red Yeast Rice has been found to contain undeclared lovastatin, a previously approved drug indicated for the treatment of high cholesterol, making this an unapproved new drug.

Red Yeast Rice is used as a dietary supplement for lowering cholesterol. Consumers who use supplements found to contain lovastatin in rare cases could result in serious muscle injury; particularly if taking with prescription "statins" such as lovastatin, simvastatin, or atorvastatin. Pregnant women could theoretically put their unborn child at risk by using this product with undeclared lovastatin. Patients with pre-existing liver disease may be at an increase risk for liver injury following chronic use of statins.

The product is packaged in white plastic bottles with an orange flip-top lid, and a clear tamper evident outer seal number of units with the UPC code 753950001183. Red Yeast Rice product includes the following lot 3121005 and expires February 2017.

Red Yeast Rice was distributed nationwide through retail and internet outlets.

The full recall can be found at www.fda.gov/Safety/Recalls/ucm402584.htm.