FDA-linked recall pulls Lipofit Extreme Fat Burner 2.0 over undeclared fluoxetine and toxic DNP

DAVIE, Fla. - A Florida company recalled Lipofit Extreme Fat Burner 2.0 nationwide after Food and Drug Administration lab work found two undeclared ingredients, including a toxic industrial chemical, Fox Business and an FDA company announcement said.

Ana Salazar Modela Tu Cuerpo Inc. is recalling lot 25M12F, expiration date September 2027. FDA analysis found undeclared fluoxetine in the daytime AM tablets and undeclared 2,4-dinitrophenol, or DNP, in the nighttime PM tablets. Fluoxetine is the active ingredient in approved antidepressants. DNP is used as a pesticide, dye, wood preservative and herbicide. It is not approved for any human use and has been illegally sold for weight loss.

The company said products with fluoxetine and DNP cannot be sold as dietary supplements and that Lipofit Extreme Fat Burner 2.0 is an unapproved new drug. Possible effects listed in the notice include nausea, vomiting, sweating, dizziness, headaches, dangerous heart rhythms, rapid heart rate, cardiac arrest, seizures, abnormal bleeding, suicidal thoughts and dangerously high body temperature. Long-term harm can involve the eyes, skin, bone marrow, nervous system and heart. Risk can rise when the product is mixed with other medicines.

Fox Business noted the FDA had already urged consumers in June not to buy the product over the same hidden ingredients. The company said it had received no known adverse-event reports tied to the recall. The tablets were sold online directly to consumers across the country.

Buyers are told to stop use at once, keep the bottles away from children and others, and contact the company for disposal steps rather than mailing or tossing the product without instructions. Anyone with symptoms should see a clinician.