Dream Body Weight Loss is recalling all lots of its Dream Body dietary supplements after they were found to contain sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to serious health risks.
The recall includes Dream Body Extreme Gold 800mg 30 gold capsules, Dream Body 450mg 30 white capsules, and Dream Body Advanced 400mg 30 purple capsules. The product is packaged in clear packer jars and brown foil packets. The affected Dream Body 450mg, Dream Body Extreme Gold 800mg and Dream Body Advanced 400mg with UPC codes 6903023120128 were distributed nationwide from January 2013 to June 16, 2016, to consumers through retail stores and internet sites.
Random testing of the supplements determined that they contain sibutramine, which is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk to individuals with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
“This undeclared ingredient makes these products unapproved new drugs for which safety and efficacy have not been established,” the Food and Drug Administration (FDA) warned. “These products may also interact in life-threatening ways with other medications a consumer may be taking.
The FDA urges consumers with these dietary supplements to stop using them immediately and discard them. Consumers who experience any health problems that may be related to taking these products should contact their health care provider.
Any side effects or adverse events related to products in this recall should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.