Medication Monitor



Generic Name (Trade Name—Company)
Notes
February 27, 2019

Weight-loss supplement

(Golean Detox capsules—Golean Detox USA)
Recalled weight-loss supplement contains undeclared sibutramine and phenolphthalein

Golean Detox USA is voluntarily recalling all lots within expiry of Golean Detox capsules, marketed as a dietary supplement for weight loss. An FDA analysis found that the capsules contain undeclared sibutramine and phenolphthalein.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market because of safety concerns. Phenolphthalein was once an ingredient used in OTC laxatives, but because of concerns about carcinogenicity, it is not currently approved for marketing in the United States.

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. Health risks of ingesting phenolphthalein could include potentially serious GI disturbances, irregular heartbeat, and cancer with long-term use. These products may also interact in life-threatening ways with other medications a consumer may be taking. 

The product is packaged in 14 packets containing two capsules per packet, a total of 28 capsules per box (UPC 8 938510 909013), and was sold nationwide to customers on Facebook at www.goleandetoxus.com.

The company is notifying its customers and is arranging for return of all recalled products. To date, Golean Detox USA  has not received any reports of adverse events related to this recall.