Lipofit fat burner recalled after FDA finds hidden prescription drug and DNP

What was recalled

The recalled product is Lipofit Extreme Fat Burner 2.0, marketed as a dietary supplement for weight loss and packaged as daytime (AM) and nighttime (PM) tablets. One lot is affected: Lot 25M12F, expiration date 09/2027. The recall is to the consumer level, meaning it reaches the people who bought the product, not only distributors.

The recalling company is Ana Salazar Modela Tu Cuerpo Inc. of Davie, Florida. The notice gives no unit count, so the number of bottles in circulation is not public. The product was distributed in the United States directly to individual consumers through online sales; no stores or marketplaces are named.

The company says it has stopped selling and promoting the affected product and has quarantined all remaining inventory under its control. FDA posted the company's announcement on Aug. 31, 2026 under the product types Dietary Supplements and Drugs. FDA notes that it posts company announcements as a public service and does not endorse the product or the company.

Why the product was recalled

FDA laboratory analysis found the product tainted with two substances that are not on the label. Per the company's notice:

• Fluoxetine, found in the AM tablets, is an active ingredient in an FDA-approved drug used to treat conditions including depression, bulimia and obsessive-compulsive disorder.
• 2,4-Dinitrophenol (DNP), found in the PM tablets, 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 FDA for any use.

Products containing fluoxetine and DNP cannot be marketed as dietary supplements. The notice states that Lipofit Extreme Fat Burner 2.0 is an unapproved new drug for which safety and efficacy have not been established, and is therefore subject to recall.

The notice's risk statement says that, tainted with both substances, the product “can cause a wide range of serious and potentially life-threatening adverse effects.” It lists nausea, vomiting, sweating, dizziness and headaches; dangerous heart rhythm problems, rapid heart rate and cardiac arrest, which can result in sudden death; seizures, abnormal bleeding and suicidal thoughts; and, with long-term exposure, damage to the eyes, skin, bone marrow, nervous system and heart, dangerously high body temperature and rapid breathing. It adds that combining the product with certain other medications further raises the risk of fatal cardiac events.

Where the product was sold

The notice says the product was distributed in the United States directly to individual consumers through online sales. It does not name a website, marketplace or social platform, and it lists no stores or distributors.

That matters for identification, because there is no retailer to notify you. If you ordered a Lipofit product online, check your order confirmations, email receipts and payment records for the Lipofit brand or the company name Ana Salazar Modela Tu Cuerpo Inc., then compare the lot number on the packaging with 25M12F.

Because the recall is nationwide and consumer-level, your location does not narrow it down; anyone in the U.S. who bought lot 25M12F is included. The company says it has stopped selling the product. The notice does not address resale by third parties.

Other FDA-posted recalls from late August 2026 include the Vitruvias thyroid tablets recall, a prescription drug recall, and the Kofinas garlic olive oil recall.

How to identify the recalled lot

The notice identifies the product by name, lot and expiration date only. It gives no UPC, bottle size or tablet count, so check the packaging for the three details in the table. If the lot code is unreadable, contact the company with a photo of the label rather than guessing.

If your packaging shows a different lot, it is not part of this announcement. The notice does not comment on other lots one way or the other, so this article cannot say whether they were tested.

Reported adverse events

The company states that, to date, it has not received any known reports of adverse events related to this recall. FDA's posting lists no illnesses either.

The notice asks consumers who have experienced any problems that may be related to taking or using the product to contact their physician or healthcare provider. Adverse reactions or quality problems can be reported to FDA's MedWatch program online at fda.gov/medwatch/report.htm, or by mail or fax using the form at fda.gov/MedWatch/getforms.htm; call 1-800-332-1088 to request a form, or fax completed forms to 1-800-FDA-0178.

The risk statement quoted above is the notice's description of what the two substances can do. It is not a report of what happened to any user, and this article adds no symptoms beyond those the company listed.

What to do if you have it

The notice's instructions, quoted: “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.” And: “Consumers who purchased the recalled product should contact Ana Salazar Modela Tu Cuerpo Inc. at (954) 305-1004 or yandrydy@gmail.com for instructions regarding the disposition of the recalled product. Consumers should not mail or dispose of the product until appropriate return or disposition instructions are provided.”

Note the sequence: do not throw the tablets out or ship them anywhere until the company tells you how. The notice does not mention a refund, replacement or reimbursement; it speaks only of return or disposition instructions, so this article makes no promise about money back.

1. Stop taking the AM and PM tablets immediately.
2. Keep the product separated from children and other people; do not sell, give or transfer it to anyone.
3. Contact Ana Salazar Modela Tu Cuerpo Inc. at (954) 305-1004 or yandrydy@gmail.com and ask for return or disposition instructions.
4. Hold the product until those instructions arrive; do not mail or dispose of it before then.
5. If you have had any problems that may be related to the product, contact your physician or healthcare provider, and consider reporting to FDA MedWatch.

Who issued the recall and when

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc., Davie, Florida. Company announcement date: Aug. 27, 2026. FDA publish date: Aug. 31, 2026. Product type: Dietary Supplements; Drugs. Reason: undeclared fluoxetine and 2,4-dinitrophenol (DNP). Recall level: consumer. The company says the recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

The announcement does not state an FDA recall classification (Class I, II or III). If one is assigned, it would appear in FDA's enforcement reports rather than in the company announcement. The document is a company notice posted by FDA, not an FDA press release, and it mentions no regulatory action beyond the recall.

The FDA page was current as of Aug. 31, 2026. Check the notice link in the sources below for any later updates. Another late-August drug recall, the Baxter and B. Braun IV solution recalls, involves hospital products rather than consumer goods.

How to monitor recalls and why to keep your receipts

No single feed covers every recall. Check the FDA recalls page for food, drugs, supplements and cosmetics, the CPSC recalls page for household products and toys, USDA FSIS recalls for meat and poultry, FoodSafety.gov alerts, and the NHTSA VIN lookup for vehicles. Retailers often notify account holders about recalled purchases, and brands post notices on their own sites; a product sold directly online, like this one, may only be announced through the company and FDA.

Keep receipts, order confirmations and photos of packaging, lot codes, expiration dates and UPCs. Those records may matter if a company refund, reimbursement or a future claim program becomes available, and they prove what you bought and when. Owed tracks open class action settlements, which are separate from recalls; our guide to filing a class action claim explains how claim programs work when they exist.

Glossary

Consumer-level recall

A recall that extends to individual purchasers, not just wholesalers or retailers. Consumers are expected to stop using the product and follow the company's instructions.

Undeclared ingredient

A substance present in a product but not listed on its label. Here, fluoxetine in the AM tablets and DNP in the PM tablets.

Fluoxetine

Per the notice, an active ingredient in an FDA-approved drug used to treat conditions including depression, bulimia and obsessive-compulsive disorder.

2,4-Dinitrophenol (DNP)

Per the notice, a toxic substance commonly used as a pesticide, dye, wood preservative and herbicide, illegally marketed for weight loss and not approved by FDA for any use.

Lot number

A production batch code printed on packaging, here 25M12F. Recalls are often limited to specific lots.

MedWatch

FDA's program for reporting adverse reactions and quality problems with drugs, supplements and other regulated products.

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