Doctor’s Best Red Yeast Rice Recalled for Hidden Lovastatin

June 25, 2014 — The U.S. Food and Drug Administration (FDA) is warning consumers not to use Doctor’s Best Red Yeast Rice because it contains a hidden, undeclared pharmaceutical ingredient.

Laboratory tests discovered lovastatin, a cholesterol-lowering prescription medication that is sold by Merck & Co. under the brand-name Mevacor.

Doctor’s Best has not received any reports of adverse events. However, federal law prohibits pharmaceutical ingredients in dietary supplements. Because lovastatin is not listed on the label, users may not realize they are at risk of adverse events.

Lovastatin is also a Pregnancy Category X, which means studies in humans or animals have demonstrated positive evidence of birth defects. The risks to a fetus clearly outweigh the potential benefits for the mother.

According to the FDA:

“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.”

Recalled Products

The recall affects about 7,379 bottles of Red Yeast Rice dietary supplements, 600-mg capsules in 120-count bottles. It was sold nationwide and marketed for lowering cholesterol. The bottle has an orange flip-top lid, UPC code 753950001183, Lot 3121005 and expires February 2017.

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