WASHINGTON (WOWO) — A weight-loss supplement is being recalled nationwide after Food and Drug Administration testing found two undeclared ingredients, including a toxic chemical that federal officials warn is extremely dangerous and is not approved for use in humans.

Florida-based Ana Salazar Modela Tu Cuerpo Inc. has recalled Lipofit Extreme Fat Burner 2.0 after FDA analysis found undeclared fluoxetine in the product’s daytime, or AM, tablets and 2,4-dinitrophenol, commonly known as DNP, in the nighttime, or PM, tablets.

The recall affects product with lot number 25M12F and an expiration date of September 2027. The supplement was sold directly to consumers through online sales and distributed nationwide.

The FDA warned consumers in June not to purchase Lipofit Extreme Fat Burner 2.0 because of the presence of the undeclared substances.

Fluoxetine is an active ingredient in several FDA-approved prescription medications used to treat conditions including depression, obsessive-compulsive disorder and bulimia. Its presence in an unapproved dietary supplement creates potential risks because consumers may not know they are taking the drug or how much they are receiving.

DNP poses an even more serious concern.

The FDA describes 2,4-dinitrophenol as a toxic substance that has been illegally marketed for weight loss. It is not approved by the agency for any use in humans and has industrial applications that include use as a pesticide, herbicide, dye and wood preservative.

The company said products containing fluoxetine or DNP cannot legally be marketed as dietary supplements.

“Lipofit Extreme Fat Burner 2.0 is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall,” the company’s recall announcement states.

DNP has a long history of being associated with severe poisoning. Medical literature has documented cases involving dangerously elevated body temperatures, rapid heart rates and potentially fatal complications. Deaths and cases of blindness linked to DNP in the 1930s contributed to the push for stronger federal regulation of drugs.

A review published by U.K. medical researchers in 2011 found that DNP can produce rapid weight loss but can also result in serious adverse effects, including death.

The recalled supplement can cause potentially life-threatening symptoms, according to the company’s announcement. Those symptoms can include nausea, vomiting, excessive sweating, dizziness and headaches.

More serious reactions can include a rapid heartbeat, abnormal heart rhythms, dangerously high body temperature, rapid breathing, seizures and cardiac arrest. The announcement also warns of possible abnormal bleeding and suicidal thoughts.

Long-term exposure or serious poisoning can potentially damage multiple organs and systems, including the eyes, skin, bone marrow, nervous system and heart.

The company also warned that the risk of fatal heart-related complications could increase if the product is taken with certain other medications.

So far, Ana Salazar Modela Tu Cuerpo Inc. said it has not received reports of adverse events associated with the recalled product.

Consumers who have taken the supplement and are experiencing symptoms that could be related to it are urged to contact a health care provider.

Anyone who has Lipofit Extreme Fat Burner 2.0 matching the recalled lot and expiration date should stop using it immediately and keep it away from children and other people.

Consumers should contact Ana Salazar Modela Tu Cuerpo Inc. for instructions regarding return or disposal of the product. The recall notice specifically advises consumers not to mail or throw away the supplement until they have received appropriate instructions for its return or disposition.

The recall is another warning from federal regulators about weight-loss products that contain pharmaceutical ingredients or chemicals that are not disclosed on the label.

The FDA has repeatedly warned that products marketed for weight loss can contain hidden active ingredients that may expose consumers to serious or potentially fatal health risks without their knowledge.

In this case, the concern involves both an undisclosed prescription drug ingredient and DNP, a highly toxic chemical that is not approved as a human weight-loss treatment.

Consumers who believe they have experienced an adverse reaction after using the recalled product should seek medical advice and can report potential problems to the FDA.