Smart Lipo365 Dietary Supplement Recall [US]

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US/Silver Spring: SmartLipo365 recalls 122 lots of Smart Lipo 800, 900, 950 mg capsules due undeclared sibutramine, desmethylsibutramine and phenolphthalein, all restricted and/or withdrawn drugs. FDA:

Direct link:

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Supplements are subject to this recall:

  • Smart Lipo, marketed as a dietary supplement and packaged in bottles of 30 capsules, with 22 bottles of 800 mg, 77 bottles of 900 mg, and 23 bottles of 950 mg in strength. The affected Smart Lipo products include the following expiration dates: 800 mg capsules: 9/15/2017; 900 mg capsules: 7/30/2017; 950 mg capsules: 7/30/2017 & 7/30/2018.

Smart Lipo was sold in stores, Centro Naturista in Richardson, TX, SmartLipo365 in Arlington, TX, as well as distributed nationwide via the Internet from

According to the FDA, Sibutramine is an appetite suppressant that was withdrawn from the US market in October 2010. 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 third drug, Phenolphthalein, is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity (i.e., its ability to possibly cause Cancer), it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

These three undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking.

If you believe you have purchased or have in your possession these recalled Supplements, please do not consume them. Instead, kindly return the product to the store where you purchased it for a full refund.

If you have any questions about this recall, please contact SmartLipo365 at 1-(800)-547-6365, 10:00 AM to 5:00 PM Central Time or on the Web at

Please note: additional Dietary Supplements from this manufacturer have been recalled subsequent to this initial posting. To see all notifications related to this product, please search for “Smart Lipo” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to Dietary Supplements, please search for “supplements” using the Search Box at the top of this page.

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Additional information about this recall:
Recalls Direct RIN: 5405-2015
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