Weight Loss Pills Recalled After FDA Finds Hidden Ingredients
A weight loss supplement recall is underway after FDA testing found something rather alarming inside pills sold online in the U.S.
Lipofit Extreme Fat Burner 2.0 has separate pills for daytime and nighttime use, but neither one disclosed everything the customers were getting. The AM tablets had an undeclared prescription drug ingredient. And the PM tablets had a toxic chemical that isn't approved by the FDA for any use.
Here's what we know.
One Lot Is Being Recalled
Ana Salazar Modela Tu Cuerpo Inc. has issued a voluntary FDA recall of Lipofit Extreme Fat Burner 2.0.
The affected product can be identified by:
Lot Number: 25M12F
Expiration Date: 09/2027
It was sold directly to customers online in the U.S.
The recall announcement is dated August 27th and was published by the FDA on August 31st.
The Daytime Pills Contained Fluoxetine
The first surprise was hiding in the AM tablets. FDA testing found fluoxetine, an ingredient used in an FDA-approved prescription medication for conditions including:
Depression
Bulimia
Obsessive-compulsive disorder
Yet, it wasn't listed on the label. And fluoxetine isn't a harmless extra ingredient.
It can cause serious side effects, including abnormal bleeding and seizures, and interact with other medications. In some combinations, those interactions can lead to dangerous heart rhythm problems or sudden death. So, someone taking these weight loss pills could also have been taking a prescription drug ingredient without knowing it.
The Nighttime Pills Are Even More Alarming
The PM tablets contained something completely different.
According to an earlier FDA safety warning, lab testing found 2,4-dinitrophenol, commonly known as DNP. DNP is a toxic substance used in products like:
Pesticides
Dyes
Wood preservatives
Herbicides
It has also been illegally marketed for weight loss. The FDA hasn't approved it for any use. Exposure can cause:
Nausea
Vomiting
Sweating
Dizziness
Headaches
In more serious cases, DNP can cause:
Dangerously high body temperature
Rapid heart rate
Breathing problems
Cardiac arrest
And even death
Neither DNP nor fluoxetine was disclosed on the Lipofit label.
The FDA Flagged the Product Months Ago
The recall itself is new, but the problem isn't.
On June 4th, the FDA told people not to buy or use Lipofit Extreme Fat Burner 2.0 after its lab analysis uncovered the hidden ingredients.
At the time, the agency said the product was being promoted and sold for weight loss on various websites and could also have been available in certain retail stores. The company has since recalled the affected lot and said it’s stopped selling and promoting the product.
There’s one reassuring piece of news here. As of the recall announcement, the company hadn't received any known reports of adverse effects related to the product.
What to Do With the Pills
If you have Lipofit Extreme Fat Burner 2.0 from lot 25M12F, stop taking it. In the recall notice, people were told to keep the product away from children and not to sell it or give it away.
But, don't toss it in the trash just yet. The company is asking people to contact them at (954) 305-1004 or yandrydy@gmail.com for instructions. And, if you think you’ve experienced a health problem related to the product, contact your doctor right away.
Any issues can also be reported through the FDA's MedWatch program.
Don’t Take Another Pill
For now, the number to remember is 25M12F. If that's the lot printed on your Lipofit Extreme Fat Burner 2.0, don’t take any more of the pills.
A weight loss supplement seems like a simple solution, but people weren't told they were taking a prescription drug and a toxic chemical.
Those missing details could have serious consequences for someone's health, which is why this is one bottle that should stay firmly closed.
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