The U.S. Food and Drug Administration has announced a recall for Lipofit Extreme Fat Burner 2.0 after finding the pills contain two different contaminants, one that’s “toxic”
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NEED TO KNOW
- Lipofit Extreme Fat Burner 2.0 was recalled after the FDA found contamination with two harmful, undeclared ingredients
- The morning pills contained fluoxetine, while the evening pills had the toxic substance 2,4-dinitrophenol (DNP)
- The FDA warns the contamination poses serious risks, including heart issues, seizures, and potentially fatal side effects
A medication that claims to burn fat has been recalled due to contamination from two potentially harmful ingredients.
The manufacturer of Lipofit Extreme Fat Burner 2.0 is voluntarily recalling the product, the U.S. Food and Drug Administration says in an August 31 statement. According to laboratory analysis, both the morning and the evening tablets of Lipofit Extreme Fat Burner 2.0 were contaminated, but with different undeclared ingredients.
The morning tablets were tainted with fluoxetine. It’s FDA approved to treat depression, bulimia, and obsessive-compulsive disorder.
Credit: USFDA
The evening tablets, however, were found to contain 2,4-dinitrophenol (DNP). The FDA said in its announcement that it is a toxic substance (commonly used as a pesticide, dye, wood preservative and herbicide) that is “illegally marketed as a weight-loss product and is not approved by the FDA for any use.”
The agency shared that the recalled batch of pills — Lot 25M12F, expiration date 09/2027 — carries significant risks, explaining that when tainted with fluoxetine and DNP, the pills can cause “serious and potentially life-threatening adverse effects.” Symptoms range include nausea, vomiting, sweating, dizziness, and headaches, and can progress to dangerous heart rhythm problems, rapid heart rate, and “cardiac arrest, which can result in sudden death.”
The agency cites neurological risks like seizures, abnormal bleeding, and suicidal thoughts. Long-term exposure can cause “damage to the eyes, skin, bone marrow, nervous system, and heart, as well as dangerously high body temperature and rapid breathing. When combined with certain other medications, the risk of fatal cardiac events is further elevated.”
PEOPLE has reached out to the manufacturer Ana Salazar Modela Tu Cuerpo Inc. for comment.
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The voluntary recall comes after the FDA issued a warning to the public against purchasing or using the product due to its contamination with fluoxetine and 2,4-dinitrophenol.
The recall notes that the product was exclusively purchased online, and advises “consumers who have the affected product should stop using it immediately, keep it separated from children and other people, and should not sell, give, or transfer it to anyone else.”
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