Weight-Loss Supplement Recalled for Undeclared Sibutramine

Inaffit LLC is voluntarily recalling Natureal, a product marketed as a weight-loss dietary supplement, due to undeclared sibutramine.

The recall affects all lots of light green and dark green capsules. Pharmacists and consumers will recognize the product as a clear bottle with green capsules that were manufactured on March 12, 2015, and have an expiration date of March 11, 2017.

Sibutramine is an appetite suppressant that was withdrawn from the US market in 2010.

The ingredient is known to “substantially” increase blood pressure and/or pulse rate, which can pose a threat to the health of those with a history of coronary artery disease, congestive heart failure, stroke, or arrhythmias, according to the FDA.

Sibutramine may also interact with other medications and cause life-threatening effects.

Inaffit has been notifying customers of the recall by email and asking them to return the product. Additionally, the FDA is asking patients and health care providers to report all adverse effects to the FDA’s MedWatch Adverse Event Reporting program.

The FDA originally issued a statement about Natureal on October 1, 2015, that said consumers should avoid purchasing the product because FDA laboratory analysis confirmed the presence of sibutramine.

Additionally, the FDA statement noted a growing trend of dietary supplements containing hidden drugs and chemicals.

The FDA cautioned that these products are often marketed as “all-natural” and purport to increase sexual performance, help manage weight, or increase muscle.

“FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients,” the administration said. “Consumers should exercise caution before purchasing any product in the above categories.”