2 Dead After Allegedly Consuming Counterfeit Eli Lilly ‘Retatrutide’ Drug Not Approved for Marketing or Commercial Use; FDA Report

A bootleg version of Eli Lilly’s Retatrutide Drug, still in trial phase, has been circulating in the blackmarket, resulting in 2 deaths so far
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Retatrutide is an Eli Lilly sponsored investigational drug and is not available for public use.Etatics Inc./pexels
Author:
Mariyam F.
Published on: 
Updated on: 

The Food and Drug Administration has received reports of two deaths after allegedly consuming a bootleg version of a weight-loss drug.

The reports were obtained through a Freedom of Information Act request. The FDA did not confirm whether it had verified either report, and CBS News could not independently verify the details.

The deaths were allegedly caused by fake drugs mimicking retatrutide, an Eli Lilly manufactured drug still undergoing trial. According to FDA, the counterfeit drugs contained too much, too little or the wrong active ingredients.

What the FDA Reports Reveal About the Unverified Retatrutide Deaths?

The first death was reported in July. A healthcare professional reported on the FDA’s Adverse Event Reporting System that a 41-year-old woman with obesity went into cardiac arrest. The report lists retatrutide as the suspected  product. It also noted that the woman had obtained the drug from an unreliable source.

FDA received the report on the second death in September, that a 49-year-old patient died after a licensed nurse convinced her to buy retatrutide from an online peptide vendor. After consuming the drug, the patient experienced severe dehydration, malnutrition and succumbed to death due to cardiac arrest.

It is important to note that the reports alone don't prove that the drugs caused or contributed to patient deaths. However, these reports point to the potential dangers of an illicit market supplying unapproved drugs like retatrutide.

The FDA has stated that retatrutide cannot be used in compounding under federal law. The agency also says retatrutide is not an ingredient in any FDA-approved drug and has not been found safe and effective for any condition. Compounded drugs are not FDA-approved, and the FDA does not review them for safety, effectiveness or quality before they are marketed.

Retatrutide remains an investigational drug and is not available for public use. Eli Lilly is studying it in Phase 3 clinical trials. In India, CDSCO records show that Eli Lilly received permission to conduct clinical trials involving retatrutide. This permission is for clinical research and does not constitute approval to market the drug.

Pink colored medicine pills and vaccine vial
The adverse events were reported by submitting forms on FDA’s Adverse Event Reporting System. Anna Tarazevich/pexels

What Legal Action Has Eli Lilly Taken Against Sellers of Counterfeit Retatrutide?

The reports were submitted to the FDA’s Adverse Event Reporting System and obtained through a Freedom of Information Act request. There are no comments from the FDA regarding the verification of either of the reports. Also, Eli Lilly told CBS News that neither case was connected to a clinical trial. 

Eli Lilly highlighted that it is evident from the reports that the individuals were consuming black-market retatrutide and said it has found suspected products with the wrong amount of active ingredient and contaminants.

Eli Lilly has reportedly filed six lawsuits earlier this year in August against compounding pharmacies, medical spas and online sellers. Lilly plans to submit retatrutide for approval in early 2027. Meanwhile, it has reported more than 14,000 listings to authorities and 

Most recently, Lilly sued five companies on October 8 under accusations of selling illicit retatrutide. The companies named in the lawsuit include American Peptides, LiveWell Peptides, Cenexa Labs, Medrein Health & Aesthetics, and Medshape Weight Loss Clinic. Bloomberg Law reported that the five vendors were targeted in lawsuits filed on October 8.

A Lilly spokesperson told The Washington Post that they have settled two of the August cases, including with Texas Peptides, which agreed to stop selling the products, advise customers to stop taking them.

America’s Poison Centers Report a Surge in Retatrutide Exposures

Texas Peptides is also required to donate an undisclosed amount to America’s Poison Centers. These centers logged a massive quarterly surge in retatrutide exposures in 2026: 249 exposures in the first three months of 2026, 460 in the following three months and 862 in the three months ending in September.

America’s Poison Centers defines an exposure as contact with a substance, which does not necessarily mean poisoning or overdose. Its data are based on self-reported calls, may not capture every exposure and are preliminary and subject to change.

(Rh/MF/MSM)

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