Weight-Loss Supplement Recalled After FDA Finds Undeclared Fluoxetine and Toxic DNP
核心洞察
Ana Salazar Modela Tu Cuerpo Inc. (搜索) issued a nationwide recall of Lipofit Extreme Fat Burner 2.0 (搜索) (Lot 25M12F, exp. 09/2027) after FDA analysis found undeclared ingredients.
The daytime (AM) tablets contain undeclared fluoxetine, while the nighttime (PM) tablets contain 2,4-dinitrophenol (DNP), a toxic substance not approved for any use.
The tainted product can cause potentially life-threatening effects including cardiac arrest, seizures, and sudden death, though no adverse events have been reported to date.
Florida-based Ana Salazar Modela Tu Cuerpo Inc. (搜索) has issued a nationwide recall of its weight-loss supplement Lipofit Extreme Fat Burner 2.0 (搜索) after laboratory analysis by the Food and Drug Administration (搜索) (FDA) revealed the product was tainted with two undeclared ingredients, including a toxic substance commonly used as a pesticide and herbicide. The affected product carries lot number 25M12F and an expiration date of September 2027.
The FDA analysis found the supplement to be "tainted with undeclared fluoxetine in the daytime (AM) tablets and undeclared 2,4-dinitrophenol (DNP) in the nighttime (PM) tablets." The agency had urged consumers in June not to purchase the supplements over the presence of fluoxetine and DNP.
Undeclared Ingredients and Regulatory Status
Fluoxetine is an active ingredient in FDA-approved drugs used to treat conditions including depression, obsessive-compulsive disorder, and bulimia. By contrast, 2,4-dinitrophenol (DNP) is a "toxic substance" that is illegally marketed as a weight-loss product and is not approved by the FDA for any use. DNP is commonly used as a pesticide, dye, wood preservative, and herbicide.
"Products containing fluoxetine and DNP cannot be marketed as dietary supplements. Lipofit Extreme Fat Burner 2.0 (搜索) is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall," the company announcement reads.
A 2011 review by U.K. medical researchers found that DNP can lead to rapid weight loss, but can also cause adverse effects, including death. Reports of deaths and blindness linked to DNP in the 1930s helped prompt stronger federal regulation of drugs, and the FDA has described DNP as extremely dangerous and not fit for human consumption.
Clinical Risks
According to the company announcement, Lipofit Extreme Fat Burner 2.0 (搜索) could cause a person to experience potentially life-threatening symptoms, including 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.
Seizures, abnormal bleeding, and suicidal thoughts are also possible. Long-term exposure carries additional risks, including damage to the eyes, skin, bone marrow, nervous system, and heart, as well as dangerously high body temperature and rapid breathing. The risk of fatal heart events may increase if the supplement is taken with certain other medications.
Distribution and Consumer Guidance
The tainted Lipofit Extreme Fat Burner 2.0 (搜索), packaged as AM and PM tablets, was distributed across the United States directly to consumers through online sales. Ana Salazar Modela Tu Cuerpo Inc. (搜索) has stopped selling and promoting the affected product and has quarantined all remaining inventory under its control.
To date, the company has not received any reports of adverse events in connection with the recall. Consumers who have the recalled product are instructed to stop using it immediately, keep it away from children and other people, and not sell, give, or transfer it to anyone else. Consumers should contact Ana Salazar Modela Tu Cuerpo Inc. (搜索) at (954) 305-1004 or [email protected] for disposition instructions, and should contact a healthcare provider if they have experienced any symptoms that may be related to the affected product. Adverse reactions or quality problems may also be reported to the FDA's MedWatch Adverse Event Reporting program.