Weight loss supplement recalled over toxic substance, other undeclared ingredient

(NEXSTAR) — A weight loss supplement has been recalled over the presence of two undeclared ingredients, including a substance commonly used as a pesticide and herbicide.

According to a recall notice shared by the U.S. Food and Drug Administration on Tuesday, those who have purchased select containers of Lipofit Extreme 2.0 Fat Burner, sold online nationwide, should stop using it immediately.

Ana Salazar Modela Tu Cuerpo Inc. issued the recall after an FDA analysis found the supplement “to be tainted with undeclared fluoxetine in the daytime (AM) tablets and undeclared 2,4-dinitrophenol (DNP) in the nighttime (PM) tablets.” The FDA previously warned consumers not to buy the supplements back in June over the presence of the fluoxetine and DNP.

Fluoxetine has been used in FDA-approved drugs for the treatment of depression, obsessive-compulsive disorder, and bulimia. It has also been used by those with premenstrual dysphoric disorder and panic disorders, according to the Mayo Clinic .

2,4-Dinitrophenol, or DNP, meanwhile, “is a toxic substance … that is illegally marketed as a weight-loss product and is not approved by the FDA for any use,” the notice shared by the FDA reads. A 2011 study out of the UK found that while DNP was reportedly linked to rapid weight loss, it can cause adverse effects, including death. Researchers said several deaths in the 1930s led the FDA to declare DNP as “extremely dangerous and not fit for human consumption.”

“Products containing fluoxetine and DNP cannot be marketed as dietary supplements,” the Tuesday notice from the FDA read. “Lipofit Extreme Fat Burner 2.0 is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.”

Because of the presence of fluoxetine and DNP, officials warn that Lipofit Extreme Fat Burner 2.0 could cause a consumer to experience potentially life-threatening symptoms, including “nausea, vomiting, sweating, dizziness, and headaches, as well as dangerous heart rhythm problems, rapid heart rate, and cardiac arrest, which can result in sudden death.”

Seizures, abnormal bleeding, and suicidal thoughts may also occur, and long-term damage could occur to the eyes, skin, bone marrow, nervous system, and heart. The risk of fatal heart events may increase if this supplement is taken with certain other medications, according to the alert.

If you are experiencing any of the aforementioned symptoms after taking Lipofit Extreme Fat Burner 2.0, you are advised to speak with a health care provider. Adverse reactions can be reported on the FDA’s website .

So far, there have been no reports of adverse effects.

Recalled packages of Lipofit Extreme Fat Burner 2.0, which include AM and PM tablets, have a lot number of 25M12F and an expiration date of 09/2027.

If you have a recalled package, you are advised not to consume it. Instead, you are encouraged to contact Ana Salazar Modela Tu Cuerpo Inc. at (954) 305-1004 or by emailing yandrydy@gmail.com for details on how to handle the product. The recall notice says you should not return or dispose of the product until you have contacted the company for instructions.