Undeclared Fluoxetine, DNP Trigger Recall of Lipofit Extreme Fat Burner 2.0

A weight-loss supplement sold online across the United States has been pulled from the market after laboratory testing revealed it was secretly spiked with a prescription antidepressant and a toxic industrial chemical linked to sudden cardiac death. Ana Salazar Modela Tu Cuerpo Inc., based in Davie, Florida, announced a nationwide voluntary recall of ‘Lipofit Extreme Fat Burner 2.0’ on August 27, 2026, after the U.S. Food and Drug Administration (FDA) confirmed the presence of undeclared fluoxetine and 2,4-dinitrophenol (DNP) in the product.

The FDA published the company’s recall notice on August 31, 2026, warning that consumers who purchased the supplement face serious, potentially life-threatening health risks.

What Triggered the Recall

According to the company’s announcement, FDA laboratory analysis found that the daytime (AM) tablets in the Lipofit Extreme Fat Burner 2.0 system contained undeclared fluoxetine, an active ingredient found in FDA-approved antidepressant medications used to treat depression, bulimia and obsessive-compulsive disorder. The nighttime (PM) tablets, meanwhile, tested positive for undeclared 2,4-dinitrophenol, commonly known as DNP.

DNP is not approved by the FDA for any human use. It is typically used industrially as a pesticide, dye and wood preservative, and it has been illegally marketed for years as a rapid weight-loss aid despite a long history of causing severe injury and death. Because the product contains both an unapproved drug ingredient and a substance that cannot legally appear in a dietary supplement, the FDA classified Lipofit Extreme Fat Burner 2.0 as an unapproved new drug, subject to recall.

Recalled Products at a Glance

The recalled item is ‘Lipofit Extreme Fat Burner 2.0,’ a two-part dietary supplement system sold as separate AM and PM tablets. The affected batch is identified as Lot 25M12F, with an expiration date of 09/2027. The product was distributed directly to individual consumers nationwide exclusively through online sales; no retail store distribution was listed in the announcement.

What Went Wrong

The company’s risk statement is blunt about the danger. When tainted with both fluoxetine and DNP, the supplement ‘can cause a wide range of serious and potentially life-threatening adverse effects,’ including nausea, vomiting, sweating, dizziness and headaches. More alarming are the cardiovascular risks: users may experience dangerous heart rhythm problems, rapid heart rate and cardiac arrest, which can result in sudden death.

The company also warned of neurological effects, including seizures, along with abnormal bleeding and suicidal thoughts. Long-term exposure to DNP in particular is associated with damage to the eyes, skin, bone marrow, nervous system and heart, as well as dangerously elevated body temperature and rapid breathing. Combining the tainted product with certain other medications further raises the risk of fatal cardiac events. As of the announcement date, Ana Salazar Modela Tu Cuerpo Inc. said it had not received any reports of adverse events tied to the affected lot.

Who Should Be Concerned

Because the product was sold nationwide through direct-to-consumer online orders, anyone in the United States who purchased Lipofit Extreme Fat Burner 2.0 — particularly Lot 25M12F — could be affected. The company has since stopped selling and promoting the product and says it has quarantined all remaining inventory still under its control.

Steps Consumers Should Take

Consumers who have the recalled tablets in their possession are urged to stop using the product immediately. The company advises keeping it away from children and other household members, and it should not be sold, given away or transferred to anyone else.

Anyone who purchased the recalled lot should contact Ana Salazar Modela Tu Cuerpo Inc. directly at (954) 305-1004 or by email at yandrydy@gmail.com for instructions on how to properly dispose of or return the product. The company has asked consumers not to mail back or discard the product until they receive specific disposition instructions. Anyone who has experienced symptoms possibly related to using the product should contact a physician or healthcare provider right away.

What the Company Said

The recall announcement states that adverse reactions or quality problems linked to the product can also be reported to the FDA’s MedWatch Adverse Event Reporting program, either online at fda.gov/medwatch/report.htm, or by requesting a paper form by calling 1-800-332-1088 and submitting it by mail or fax to 1-800-FDA-0178. The company noted that the recall ‘is being conducted with the knowledge of the U.S. Food and Drug Administration.’