FDA Issues Nationwide Recall for Weight Loss Supplement Containing Toxic Pesticide and Undeclared Drugs

A nationwide recall has been issued for the weight loss supplement Lipofit Extreme Fat Burner 2.0 due to the discovery of undeclared ingredients, including a highly toxic substance often used in pesticides and herbicides.

Florida-based Ana Salazar Modela Tu Cuerpo Inc. announced the recall affecting products with lot number 25M12F and an expiration date of September 2027. The recall follows a Food and Drug Administration (FDA) analysis which determined that the daytime (AM) tablets contained undeclared fluoxetine, while the nighttime (PM) tablets contained undeclared 2,4-dinitrophenol (DNP).

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Ana Salazar Modela Tu Cuerpo Inc. issued a nationwide recall for Lipofit Extreme Fat Burner 2.0. (iStock / iStock)

While fluoxetine is an FDA-approved medication used to treat conditions such as depression, obsessive-compulsive disorder, and bulimia, it cannot be used as an undeclared ingredient in dietary supplements. More concerning is the presence of 2,4-Dinitrophenol (DNP), a toxic substance frequently marketed illegally for weight loss. DNP is not approved for human consumption by the FDA and is typically utilized as a dye, wood preservative, herbicide, or pesticide.

“Products containing fluoxetine and DNP cannot be marketed as dietary supplements. Lipofit Extreme Fat Burner 2.0 is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall,” the company stated in its announcement.

Medical research dating back to 2011 has indicated that while DNP may induce rapid weight loss, it carries severe risks, including death. Historically, reports of blindness and fatalities linked to DNP in the 1930s led to stringent federal regulations. The FDA continues to classify DNP as extremely dangerous and unfit for human use.

The FDA urged consumers in June not to purchase the supplements over the presence of the fluoxetine and DNP. (Getty Images / Getty Images)

Consuming Lipofit Extreme Fat Burner 2.0 may result in life-threatening symptoms, such as nausea, vomiting, dizziness, headaches, excessive sweating, and dangerous cardiac issues including rapid heart rate, irregular rhythms, or sudden cardiac arrest. The company also warned of potential seizures, abnormal bleeding, suicidal ideation, and long-term damage to the nervous system, skin, eyes, bone marrow, and heart. Additional risks include hyperthermia (dangerously high body temperature) and respiratory distress. The risk of fatal cardiac events may be further compounded if the supplement is taken alongside other medications.

Ana Salazar Modela Tu Cuerpo Inc. has reported no adverse events related to this recall thus far. However, consumers who have used the product and are experiencing symptoms should contact a healthcare professional immediately.

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The recall was initiated after an analysis by the Food and Drug Administration. (iStock / iStock)

The tainted Lipofit Extreme Fat Burner 2.0, sold in AM and PM tablet formats, was distributed nationally via direct-to-consumer online sales.

Consumers in possession of the recalled product are advised to stop use immediately and keep it out of reach of children. Individuals who purchased the supplement should contact Ana Salazar Modela Tu Cuerpo Inc. for specific instructions regarding disposal or returns. Do not mail or discard the product until formal instructions for return or disposition are provided by the company.

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