The Food and Drug Administation (FDA) announced that SmartLip360 is voluntarily recalling 122 lots of Smart Lipo capsules, a dietary supplement promoted for weight loss, due to the presence of undeclared ingredients.
An analysis by the Food and Drug Administration found Smart Lipo 800mg and 900mg capsules to contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein. Sibutramine is a controlled substance that was pulled from the market in October 2010 for safety concerns. Sibutramine is known to increase blood pressure and/or pulse rate in some patients. It may pose a significant risk in patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Phenolphthalein is a chemical that is not found in any approved drug in the United States. It may present a risk of cancer and may interact with other medications a consumer is taking.
The affected products are packaged in 30-count bottles of 800mg, 900mg, and 950mg. The affected Smart Lipo products include the following expiration dates:
- 800mg capsules: September 15, 2017
- 900mg capsules: July 30, 2017
- 950mg capsules – July 30, 2017 and July 30, 2018
Consumers, distributors, and retailers that have the recalled Smart Lipo should stop using the recalled product and are asked to please dispose of it.
For more information call (888) 463-6322 or visit FDA.gov.