FDA Received Reports of Two Deaths Tied to Bootleg Retatrutide

The FDA has received reports of two deaths in people who used products sold as retatrutide, Eli Lilly’s investigational triple agonist, according to agency documents first reported by CBS News on October 13. Neither report has been verified, and no one has shown that the products caused either death. Still, they appear to be the first public U.S. accounts linking unauthorized retatrutide use to a fatality, and they arrive as illicit demand for the drug keeps climbing.

Retatrutide is still in clinical development and is not approved by the FDA for any use.

Key facts

• Both deaths were submitted to the FDA Adverse Event Reporting System (FAERS) in recent months. CBS News obtained the redacted reports through a Freedom of Information Act request.
• One report, filed in July, describes a 41-year-old woman with obesity who went into cardiac arrest. The second, filed in September, describes a 49-year-old patient who had severe dehydration, malnutrition, and cardiac arrest.
• The FDA would not say whether it has verified either report. Lilly said the reports show both people were using black-market product.
• America’s Poison Centers logged 862 retatrutide exposures in the three months ending in September, up from 249 in the first quarter of 2026.
• Neither case was connected to a clinical trial. Lilly has said it plans to seek FDA approval in early 2027.

What the two reports say

The CBS News investigation describes the July report as coming from a healthcare professional. It lists retatrutide as a “suspect product” that the 41-year-old woman got from what the filer called an unreliable source. She was hospitalized with a dangerously rapid heartbeat and could not be resuscitated. The report also says she was drinking kava, a plant-based relaxant, around the time of the emergency, which makes it even harder to pin down a cause.

The September report is about a 49-year-old patient who, according to the filer, was talked into buying retatrutide from an online peptide vendor by a licensed nurse. The report says the nurse sent her a link, sold her vials, and suggested doses. It includes a photo of a vial carrying the brand name of a seller that labels its peptides “research use only.” The company’s attorney told CBS the redacted report contains no lot or batch number to check against its records. She added that the vial in the photo doesn’t match the company’s current packaging and that the FDA has not contacted the company. She also said a licensed clinician should never recommend, dose, or sell research-use-only products to a patient.

CBS said it could not independently confirm what the reports say. Adverse event reports often lack lab testing, medical records, and product analysis, so on their own they cannot establish cause and effect.

How the FDA, Lilly, and outside experts responded

The FDA said in a statement that it reviews adverse event reports and gathers more information when needed. It added that it generally does not comment on possible or ongoing compliance matters. CBS noted that FAERS was built mainly to track the safety of drugs the agency has already approved. Retatrutide is not one of them.

Lilly told CBS the reports make clear both people were taking black-market retatrutide. The company said it has found suspect products with too much active ingredient, too little, or the wrong one, plus contaminants that could seriously endanger patients. Lilly is also suing sellers of bootleg versions, arguing that bad reactions to counterfeits could damage the drug’s reputation before it ever reaches pharmacies.

Pieter Cohen, an associate professor at Harvard Medical School, told CBS the FDA should try to get hold of the products these patients actually injected and have them analyzed. He said it would be deeply concerning if the agency were not investigating aggressively.

A fast-growing gray market

The poison center figures help explain why the reports drew so much attention. Exposures reported to America’s Poison Centers rose from 249 in the first quarter of 2026 to 460 in the second quarter and 862 in the third. CBS cautioned that a steady rise is common for a drug that has only recently started being tracked.

The trend isn’t limited to the U.S. On October 19, NL Times reported that hundreds of people in the Netherlands are believed to be using retatrutide, bought mostly through TikTok. The European Medicines Agency has not yet received an application for the drug.

Researchers are also trying to document what unsupervised users experience. Medscape reported on October 15 on an analysis of roughly 10,000 Reddit users discussing retatrutide. The side effects they described, including increased appetite, fatigue, and insomnia, differed from the main effects seen in clinical trials.

How this compares with the controlled trial data

In Lilly’s phase 3 program, retatrutide was given under medical supervision with set dose-escalation schedules. In the TRIUMPH-2 results, which included adults with obesity and type 2 diabetes, gastrointestinal effects such as diarrhea and nausea were the most common adverse events. Discontinuations due to adverse events ranged from 3.8% to 11.6% across retatrutide doses, compared with 4.9% on placebo. For a full rundown of the trial program, see our retatrutide clinical trial results explainer.

Those numbers reflect pharmaceutical-grade drug given to screened participants. They say nothing about what is inside a vial bought online. According to Medscape, Lilly plans to file a Biologics License Application in the first quarter of 2027 based on its TRIUMPH trials.

What this means for researchers and buyers

• The reports are unproven. Two FAERS filings show the FDA has been told about deaths. They do not show that retatrutide, a contaminant, or something else caused them.
• Product identity matters. Lilly says it has found counterfeit products with wrong doses, wrong ingredients, and contaminants. That makes independent, batch-specific testing and traceable lot numbers central questions for anyone assessing a supplier. Our vendor rating methodology explains how we weigh testing documentation.
• Regulatory pressure is rising. These reports add to growing scrutiny of the peptide market, including the FDA’s pending compounding policy, which we covered in our report on the interim peptide compounding policy.
• Retatrutide remains investigational. It is not FDA-approved, and products sold “for research use only” are not meant for human use.

We will update this story if the FDA releases more information or opens an investigation.