Nationwide Recall of Weight Loss Supplement Due to Hazardous Ingredients

A weight loss supplement has been pulled from the market due to the presence of two undeclared substances, one of which is a toxic chemical often found in pesticides and herbicides.

Ana Salazar Modela Tu Cuerpo Inc., located in Florida, announced a nationwide recall for its Lipofit Extreme Fat Burner 2.0. The products affected have a lot number of 25M12F and an expiration date set for September 2027.

This recall was prompted by an FDA analysis that uncovered the supplement was “contaminated with undeclared fluoxetine in the daytime (AM) tablets and undeclared 2,4-dinitrophenol (DNP) in the nighttime (PM) tablets.”

The FDA had already advised consumers in June against buying these supplements because of the presence of fluoxetine and DNP.

Fluoxetine is an ingredient found in FDA-approved medications used to treat various mental health conditions, including depression and obsessive-compulsive disorder. In stark contrast, 2,4-dinitrophenol (DNP) is considered a “toxic substance” that is not approved by the FDA for any purpose. Instead, it is typically employed in industrial applications such as pesticides and dyes.

According to the company’s statement, “Products containing fluoxetine and DNP cannot be marketed as dietary supplements. Lipofit Extreme Fat Burner 2.0 is an unapproved new drug for which safety and efficacy have not been established, and, therefore, is subject to recall.”

A review from 2011 by U.K. medical researchers highlighted that while DNP can lead to quick weight loss, it is also linked to serious side effects, including death. Historical reports of fatalities and vision loss associated with DNP back in the 1930s motivated stricter drug regulations. The FDA categorizes DNP as extremely hazardous and unsuitable for human consumption.

This product could lead to severe health issues, such as nausea, vomiting, dizziness, and dangerous heart problems, including arrhythmias and even cardiac arrest, which may result in sudden death, the company noted.

In addition, symptoms like seizures, unusual bleeding, and suicidal thoughts have been reported as possible side effects. Long-term usage may lead to damage to vital organs like the eyes, skin, heart, and nervous system, not to mention a risk of hyperthermia and rapid breathing.

There’s also a heightened risk of fatal heart complications if the supplement is combined with other medications.

So far, Ana Salazar Modela Tu Cuerpo Inc. has not received any reports of adverse reactions related to the recalled product. Individuals who may have experienced any symptoms associated with it are encouraged to consult a healthcare provider.

The tainted Lipofit Extreme Fat Burner 2.0, sold as AM and PM tablets, was distributed widely across the country through online sales.

Consumers who have this product on hand should stop using it immediately and keep it away from children and others. Anyone who purchased it should reach out to Ana Salazar Modela Tu Cuerpo Inc. for guidance on how to properly dispose of it. It’s advised not to send back or discard the product until return instructions are given.