SmartLipo365 initiates voluntary nationwide recall due to undeclared ingredients

SmartLipo365 issued a voluntary recall of Smart Lipo (800, 900, 950 mg) capsules as a result of undeclared sibutramine, desmethylsibutramine and phenolphthalein, according to a press release from the FDA.

The FDA found the substances in test samples of the products it received from SmartLipo365.

Sibutramine acts as an appetite suppressant and was withdrawn from the U.S. market in 2010. It can substantially raise blood pressure and/or pulse rate, according to the release.

Phenolphthalein was previously used in over-the-counter laxatives, but with concerns for carcinogenicity, it is no longer U.S. approved for marketing. The drug can cause potentially serious gastrointestinal disturbances, irregular heartbeat and cancer with long-term use.

The affected Smart Lipo products include the following expiration dates: 800 mg capsules – 9/15/2017, 900 mg capsules – 7/30/2017, 950 mg – 7/30/2017 and 7/30/2018. Smart Lipo was sold in Texas and distributed nationwide via the internet.

SmartLipo365 is notifying its customers and distributors via e-mail and letter and will discontinue distribution of the product.

Consumers with questions can contact SmartLipo365 by calling 1-800-547-6365 or info@smartlipo365.com.

Reference : www.fda.gov/safety/recalls