Safety

Red Yeast Rice by Doctor’s Best: Recall - Undeclared Lovastatin

[Posted 06/24/2014]

AUDIENCE: Consumer

ISSUE: Doctor’s Best is voluntarily recalling lot 3121005 (7379 bottles) of Red Yeast Rice dietary supplement, 600 mg Capsules, 120-count bottles to the retail level. Doctor’s Best 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.

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.

BACKGROUND:  Doctor’s Best Red Yeast Rice was distributed nationwide through retail and internet outlets.  Doctor’s Best Red Yeast Rice is marketed as a dietary supplement for lowering cholesterol and is packaged in white plastic bottle with an orange flip-top lid, and a clear tamper evident outer seal. UPC code 753950001183, Lot 3121005 and expires February 2017.

RECOMMENDATION: Consumers/distributors/retailers that have Red Yeast Rice which is being recalled should discontinue usage and return the unused portion to their place of purchase. Doctor’s Best is notifying its distributors and customers by mail and is arranging for return of all recalled products.

Consumers with questions regarding this recall can contact Doctor’s Best at 1-844-717-0190 Monday through Friday 9am to 5pm PDT and contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

[06/24/2014 - Press Release - Doctor’s Best]

Photo: Product Labels

Page Last Updated: 06/24/2014
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