The FDA and GMP Herbal Products have notified healthcare professionals and consumers of a voluntary recall of Pai You Guo, a weight loss dietary supplement, due to the presence of undeclared drug ingredients. FDA lab analyses found the products to contain undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss; and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the U.S.
These products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
The FDA has not approved the Pai You Guo products as a drug; therefore the safety and effectiveness of this product is unknown. All lots of Pai You Guo products, sold either in a box of 30 capsules or a bag of 10 g powder, are being recalled.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190531.htm.