A weight-loss supplement distributed across the United States, including to consumers in Aiken, was recalled on August 27, 2026, after laboratory analysis by the Food and Drug Administration (FDA) revealed it contained undeclared pharmaceutical ingredients. Ana Salazar Modela Tu Cuerpo Inc. initiated the recall for one lot of Lipofit Extreme Fat Burner 2.0.
The FDA analysis found fluoxetine in the AM tablets and 2,4-dinitrophenol (DNP) in the PM tablets of the Lipofit Extreme Fat Burner 2.0. Fluoxetine is an active ingredient in FDA-approved medications for conditions such as depression, bulimia, and obsessive-compulsive disorder. DNP is a toxic substance not approved by the FDA for any use, commonly employed as a pesticide, dye, wood preservative, and herbicide, and is illegally marketed for weight loss.
Products containing fluoxetine and DNP are not permitted to be marketed as dietary supplements. The FDA indicates that Lipofit Extreme Fat Burner 2.0, when tainted with both substances, can lead to serious and potentially life-threatening adverse effects. Users may experience symptoms such as nausea, vomiting, sweating, dizziness, and headaches. More severe risks include dangerous heart rhythm problems, rapid heart rate, and cardiac arrest, which could result in sudden death. Neurological effects like seizures, abnormal bleeding, and suicidal thoughts are also possible.
Long-term exposure to these substances carries additional risks, including damage to the eyes, skin, bone marrow, nervous system, and heart. It can also cause dangerously high body temperature and rapid breathing. The risk of fatal cardiac events is further heightened when these substances are combined with certain other medications.
The recalled product, Lipofit Extreme Fat Burner 2.0, Lot: 25M12F with an expiration date of 09/2027, was sold directly to individual consumers online. As of the recall date, Ana Salazar Modela Tu Cuerpo Inc. has not received any reports of adverse events linked to this product.
Consumers who possess the recalled Lipofit Extreme Fat Burner 2.0 should cease use immediately and contact Ana Salazar Modela Tu Cuerpo Inc. for disposal instructions. Individuals who have experienced any health issues potentially related to using this product should consult their physician or healthcare provider.
