If you keep Lipofit Extreme Fat Burner 2.0 in your medicine cabinet, stop taking it.
The Florida distributor Ana Salazar Modela Tu Cuerpo Inc. issued a nationwide recall on August 27, 2026 after Food and Drug Administration lab tests found two hidden active ingredients in the pills.
The daytime tablets contain fluoxetine, the prescription antidepressant sold as Prozac.
The nighttime tablets contain 2,4-dinitrophenol, better known as DNP, an industrial chemical the FDA banned for human use in 1938.
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The recall covers lot number 25M12F with an expiration date of September 2027.
The product was sold nationwide through the distributor's website and possibly through retail locations.
What the FDA says the pills can do
FDA officials warned that people who took Lipofit could develop "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."
The agency's earlier June 4, 2026 safety notification added seizures, abnormal bleeding, suicidal thoughts, and damage to the eyes, skin, bone marrow, nervous system, and heart.
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Dangerously high body temperature and rapid breathing are also on the list.
No adverse events have been reported so far, according to the recall notice.
Why DNP is not a supplement
DNP is used as a pesticide, dye, and wood preservative.
The FDA has called it extremely dangerous and not fit for human consumption, and the 1938 Federal Food, Drug, and Cosmetic Act made it illegal in oral products.
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Operation Supplement Safety, a Department of Defense program, lists the lethal dose at about 4.3 milligrams per kilogram of body weight, or roughly 350 milligrams for a 180-pound person.
The chemical works by forcing cells to burn energy as heat instead of storing it.
That is why bodybuilders and dieters still seek it out for rapid weight loss, and it is why it can push body temperature to fatal levels. There is no specific antidote for DNP poisoning.
The FDA has been tightening enforcement against tainted weight loss products sold online.
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Earlier waves of action included 25 weight loss supplements sold as tejocote root that were found to contain a toxic ornamental plant.
The problem with hidden fluoxetine
Fluoxetine is FDA-approved to treat depression, bulimia, and obsessive-compulsive disorder, and it should be taken only under a doctor's supervision.
Slipped into a supplement without a label, it becomes more dangerous, because people already taking antidepressants, blood thinners, or common pain relievers can hit unexpected interactions.
The FDA warned that combining fluoxetine with certain other medicines can cause dangerous heart rhythm problems or sudden death.
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What to do if you have the product
Stop using the tablets and keep them away from children.
Do not throw them in the trash or mail them back until you have instructions.
Ana Salazar Modela Tu Cuerpo Inc. can be reached at (954) 305-1004 or [email protected] for return and disposal directions.
Anyone with symptoms should contact a healthcare provider and can report the case to the FDA MedWatch program at fda.gov/medwatch or by calling 1-800-FDA-1088.
This article is made and published by Ida-Marie Palm Varbæk, who may have used AI in the preparation.