Posted June 25, 2014

Red Yeast Rice Product Recalled

On June 24, 2014, Doctor's Best announced a voluntary recall of lot 3121005 (7379 bottles) of Red Yeast Rice dietary supplement, 600 mg Capsules, 120-count bottles. Red Yeast Rice 600 mg has been found to contain undeclared lovastatin, a previously approved drug indicated for the treatment of high cholesterol, making this an unapproved new drug.

ConsumerLab.com has tested red yeast rice products as part of its ConsumerLab.com's Red Yeast Rice Supplements Review. The most recent review includes a Doctor's Best Red Yeast Rice 1200, which consists of tablets containing 1,200 mg of red yeast rice and is different from the recalled product which consists of capsules containing 600 mg of red yeast rice.

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 increased risk for liver injury following chronic use of statins.

Doctor's Best has not received any reports of adverse events related to this recall.

Red Yeast Rice 600 mg is used as a dietary supplement for lowering cholesterol and is packaged in a white plastic bottle with an orange flip-top lid, and a clear tamper evident outer seal number of units, UPC code 753950001183. The recalled Red Yeast Rice 600 mg is lot 3121005 and expires February 2017.

Red Yeast Rice 600 mg was distributed nationwide through retail and internet outlets. Doctor's Best is notifying its distributors and customers by mail and is arranging for return of all recalled products.

Consumers/distributors/retailers that have Red Yeast Rice 600 mg which is being recalled should discontinue usage and return the unused portion to their place of purchase.

In ConsumerLab.com's tests of red yeast rice supplements, nearly all products contain lovastatin, although at amounts which vary by brand from less than 1 mg to more than 3 mg per pill. Lovastatin is a naturally occurring compound in properly made red yeast rice, although it is possible that a product can be adulterated with added lovastatin.

UDPATE: 3PM (EST) 6/25/14: ConsumerLab.com contacted Doctor's Best for additional information regarding this recall. According to Scott Steinford, President of Doctor's Best, the FDA recently informed his company that the 600 mg product contained lovastatin, and on that basis, requested that the company conduct a voluntary recall. The FDA has established that no amount of lovastatin, even at naturally occurring levels, is legally permitted in a supplement and, sporadically, has taken similar actions in the past.

In addition to voluntarily complying with the recall request, Doctor's Best has chosen to discontinue its entire red yeast rice line of products, including the 1,200 mg tablets. As Mr. Steinford, noted, "We could sell red yeast rice with no lovastatin, which wouldn't help anyone, but we prefer to not sell it at all."

In its most recent tests of red yeast rice products, ConsumerLab.com did identify one product on the market to contain no lovastatin.

For more information about the recall, use the link below in red.

Tests, comparisons, and review of red yeast rice supplements are found in ConsumerLab.com's Red Yeast Rice Supplements Review.