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FDA posts a nationwide recall of Lipofit Extreme 2.0 after lab analysis finds fluoxetine and DNP in the tablets

A company-initiated recall of one lot, published by the FDA on 31 August. Undeclared fluoxetine in the AM tablets, undeclared 2,4-dinitrophenol in the PM tablets — and neither was on the panel.

By Staff, Pump Verdict 2 min read

This site spends its time arguing about numbers on a Supplement Facts panel. Here the panel is not the argument: the two things that mattered were never on it.

On 27 August 2026, Ana Salazar Modela Tu Cuerpo Inc. announced a nationwide voluntary recall to the consumer level of Lipofit Extreme Fat Burner 2.0, lot 25M12F, expiry 09/2027. The FDA published the company announcement on 31 August. Per the notice, FDA laboratory analysis found the product tainted with undeclared fluoxetine in the daytime (AM) tablets and undeclared 2,4-dinitrophenol (DNP) in the nighttime (PM) tablets.

Read the mechanics before the headline. This is the company recalling its own product, conducted with the agency’s knowledge; FDA posts such announcements as a public service and endorses neither the product nor the company. No ban, no seizure, one lot — not a brand, not a category.

What the notice says was in it

Fluoxetine, the notice says, is an active ingredient in an FDA-approved drug used for depression, bulimia and obsessive-compulsive disorder. DNP it describes as a toxic substance — a pesticide, dye, wood preservative and herbicide — illegally marketed for weight loss and not approved by the FDA for any use.

The risk statement is stark: nausea and vomiting, dangerous heart rhythms, rapid heart rate and cardiac arrest that can result in sudden death, seizures, abnormal bleeding, suicidal thoughts, and organ damage on long-term exposure — the cardiac risk further elevated with certain other medications.

The careful wording on harm is the company’s own: to date it has not received any known reports of adverse events related to this recall. That is a statement about reports received, not a finding that nobody was hurt.

The recall was not the first warning

On 4 June 2026 the agency published a medication health fraud notification advising consumers not to purchase or use the product, naming the same two hidden ingredients and the same AM/PM split; the recall followed twelve weeks later.

Why a label reader should care

A panel is a claim, not a chromatogram. Reading one closely catches an underdosed pump matrix or a blend hiding its split; it cannot catch what nobody printed. The FDA said as much in June: it is unable to test and identify all products marketed as dietary supplements with potentially harmful hidden ingredients. What does reach past the artwork is an independent programme testing finished lots, which is why a certification mark is a batch claim, not a brand claim.

The recalled lot went to US consumers online. Anyone holding it is told to stop immediately, and not to mail or dispose of it until the company supplies return instructions; anyone who has had problems is told to contact a physician, and to report to FDA MedWatch. Nothing here is medical advice, and nothing in this category treats or diagnoses anything — if that lot is in your gym bag, take it up with a doctor.