Safety & Consumer Alert
FDA posts nationwide Lipofit fat-burner recall over hidden fluoxetine and DNP
The recalled AM/PM weight-loss product contains an undeclared prescription drug and a toxic chemical. Check the lot, stop using it and know when to seek urgent help.
A same-day recall for an online weight-loss product
The Food and Drug Administration posted a nationwide recall on August 31 for Lipofit Extreme Fat Burner 2.0 after laboratory testing found fluoxetine in the daytime tablets and 2,4-dinitrophenol, known as DNP, in the nighttime tablets. Neither substance was declared on the label. The company announcement, dated August 27, identifies one recalled lot and says the product went directly to U.S. consumers through online sales. This is a consumer-level recall, not a general warning about every weight-loss supplement.
Check the product name, lot and expiration date
The recalled product is an AM/PM tablet package labeled Lipofit Extreme 2.0 Fat Burner. The company identifies lot 25M12F with an expiration date of September 2027. Consumers should compare all three details—the full product name, lot and expiration date—rather than relying on package color or an online listing. The recall notice says the firm stopped selling and promoting the affected product and quarantined stock still under its control. It also says no known adverse events had been reported to the company when the announcement was issued. That statement does not establish that the product is safe.
Why hidden fluoxetine and DNP change the risk
Fluoxetine is a prescription drug used for several psychiatric conditions. An undeclared dose can expose someone to side effects and drug interactions without the patient or clinician knowing it is present. FDA lists abnormal bleeding, seizures, dangerous heart-rhythm problems and suicidal thoughts among the serious risks associated with the hidden ingredient in this product. DNP is different: FDA describes it as a toxic industrial chemical that is illegally marketed for weight loss and is not approved by the agency for any use. Poison Control notes that DNP can drive body temperature, heart rate and breathing dangerously high and that there is no antidote.
What consumers should do now
FDA and the company say consumers with the recalled lot should stop using it immediately, keep it away from children and other people, and not sell, give away or transfer it. The recall directs purchasers to contact Ana Salazar Modela Tu Cuerpo Inc. at 954-305-1004 or yandrydy@gmail.com for return or disposal instructions; it specifically says not to mail or discard the product until those instructions are provided. Anyone who has used it should tell a health professional the exact product name and keep the package or a clear photo of its label available if that can be done safely. Do not restart the recalled product.
When symptoms require urgent help
Dangerously high body temperature, rapid heartbeat, rapid breathing, severe sweating, confusion, fainting, seizure, chest pain or another rapidly worsening symptom after using this product warrants emergency care; call 911 in the United States. Poison Control offers confidential guidance at 1-800-222-1222 and through webPOISONCONTROL. Consumers and health professionals can also report a suspected adverse event to FDA MedWatch. A recall article cannot determine whether a symptom came from this product, and waiting for certainty can be unsafe when severe symptoms are developing.
A broader warning for fitness and body-image marketing
FDA first warned consumers about Lipofit Extreme 2.0 in June and now lists it in the agency's health-fraud database as a product with hidden ingredients. The database covers only products FDA has identified; absence from the list is not proof that another supplement is safe. Claims such as “natural,” “fast,” or “fat-burning” do not reveal what laboratory testing would find. Men navigating weight, athletic performance or body-image pressure deserve practical information without shame: pause before buying a supplement promoted through social media or direct messages, check the FDA database, and discuss goals and current medicines with a licensed clinician or pharmacist. NOCTI provides wellness news and provider discovery, not medical diagnosis or treatment.
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