FDA testing found an antidepressant and a banned industrial chemical in a fat burner sold online

A weight-loss supplement sold directly to consumers online has been recalled across the United States after Food and Drug Administration laboratory testing found two undeclared drug substances in it, one of them a chemical the agency has never approved for any human use.

Ana Salazar Modela Tu Cuerpo Inc., of Davie, Florida, announced the recall of Lipofit Extreme Fat Burner 2.0 on August 27, 2026. FDA published the notice on August 31. The recall covers Lot 25M12F with an expiration date of 09/2027, and reaches the consumer level, meaning people who bought it are asked to act, not just retailers.

Fluoxetine in the daytime tablets, 2,4-dinitrophenol in the nighttime tablets

The product is packaged as separate AM and PM tablets. FDA laboratory analysis found undeclared fluoxetine in the daytime tablets and undeclared 2,4-dinitrophenol, usually written as DNP, in the nighttime tablets.

Fluoxetine is a prescription antidepressant, the active ingredient in an FDA-approved drug used for conditions including depression, bulimia and obsessive-compulsive disorder. It is not something a person should take without a prescriber, and it interacts with a range of other medicines.

DNP is the more alarming of the two. FDA describes it as a toxic substance commonly used as a pesticide, dye, wood preservative and herbicide, illegally marketed as a weight-loss product, and not approved by the agency for any use. It works by making the body burn energy as heat, which is also why it can raise body temperature to dangerous levels.

Neither substance can lawfully be sold in a dietary supplement. FDA states that Lipofit Extreme Fat Burner 2.0 is an unapproved new drug for which safety and efficacy have not been established, and is therefore subject to recall.

FDA lists cardiac arrest, seizures and sudden death among possible effects

The agency's risk statement is specific. It says that when tainted with both fluoxetine and DNP, the product can cause a wide range of serious and potentially life-threatening adverse effects.

Listed effects include nausea, vomiting, sweating, dizziness and headaches, along with dangerous heart rhythm problems, rapid heart rate, and cardiac arrest, which the notice says can result in sudden death. Neurological effects including seizures may also occur, along with abnormal bleeding and suicidal thoughts. Long-term exposure carries added risks including damage to the eyes, skin, bone marrow, nervous system and heart, as well as dangerously high body temperature and rapid breathing. The notice adds that combining the product with certain other medications further raises the risk of fatal cardiac events.

As of the announcement, the company had not received any known reports of adverse events connected to the recall.

FDA says to stop use immediately and not pass the product to anyone else

The product was distributed nationwide in the United States, sold directly to individual consumers through online sales. The company says it has stopped selling and promoting it and has quarantined remaining inventory under its control.

Consumers holding the affected product are told to stop using it immediately, keep it separated from children and other people, and not sell, give or transfer it to anyone else. Buyers are directed to contact the company at (954) 305-1004 or yandrydy@gmail.com for instructions on returning it before disposing of it.

Anyone who has taken this product and has concerns about their health should raise it with a clinician, and it is worth mentioning the two named substances specifically, since fluoxetine in particular interacts with other medicines.

One lot named, and no testing reported beyond it

The recall identifies a single lot. The notice does not report testing of other lots or other products from the same seller, and it does not say how the substances entered the product. Absence of adverse event reports is also not evidence of safety: reporting is voluntary, and people who buy a supplement online are less likely than patients under a prescriber's care to connect a symptom to a product and report it.

The broader pattern is worth noting for anyone navigating obesity treatment. Products of this kind are bought without a prescriber in the loop, often by people trying to work around the cost or availability of prescription options, and their contents are unknown until a laboratory tests them.