CBS News reported on Oct. 13 that two adverse-event reports filed with the Food and Drug Administration, in July and September 2026, describe the deaths of women aged 41 and 49 and name retatrutide, an experimental Eli Lilly weight-loss drug the FDA has not approved, as a suspect product. A suspect product is the product the person filing the report believed may be involved. The reports do not establish what either woman took or that the drug caused the deaths, and CBS said it could not independently verify either one.
An adverse-event report is a report submitted to the FDA about a health problem after someone used a product. It does not prove the product caused the problem, and the details are as given by whoever filed it. These two reports are also not a count of deaths linked to retatrutide. The FDA’s own page on unapproved weight-loss drugs gives no retatrutide death or event count.
What the two reports say
CBS obtained the reports from the FDA under the Freedom of Information Act, the federal public-records law. The agency redacted details that could identify the people involved. According to CBS, the reports were submitted to the FDA Adverse Event Reporting System, a system CBS said is designed to help monitor drugs the agency has approved, which retatrutide is not. Neither report is connected to a formal clinical trial, per the documents and Lilly. CBS described them as appearing to be the first public U.S. accounts alleging that unauthorized retatrutide use played a role in a death.
The first report was filed in July by a healthcare professional. It describes a 41-year-old woman with obesity, described by the filer as otherwise healthy, who went into cardiac arrest. She was taken to a hospital with a dangerously fast heartbeat and could not be resuscitated. The report lists retatrutide as a suspect product and says it came from an unreliable source. It also says she was drinking kava at the time; CBS described that as an apparent reference to a plant-based drink known for its relaxing properties.
The second report was filed in September. It describes a 49-year-old woman who died after severe dehydration, malnutrition and cardiac arrest. The report alleges that a nurse persuaded her to buy retatrutide from an online peptide vendor, provided the link, sold her vials and recommended doses. As relayed, the report names both the nurse and the vendor’s website as sources, and the vendor’s attorney told CBS that it does not show which seller supplied the product. These are allegations in a report CBS could not verify. The nurse’s name, location and license number were redacted. The report included a photo of a vial labeled with the vendor’s name.
What is not known
- Whether either product contained retatrutide, or what else it contained. CBS did not report any laboratory testing of the vials.
- What caused either death. CBS did not report a medical examiner or coroner finding.
- What role, if any, the kava mentioned in the first report played.
- Whether the FDA has verified the reports. The agency declined to say, according to CBS, and told the outlet it reviews adverse event reports and gathers more information when needed.
- Whether the nurse’s role and the vendor link described in the second report are accurate.
What Lilly and the vendor said
Lilly told CBS that the reports make clear the two people were taking black-market retatrutide. That is Lilly’s characterization; the reports themselves do not establish which product was taken. Lilly makes retatrutide and has a commercial interest in how these cases are described. The company said it has found suspect products with too much, too little or the wrong active ingredient, along with contaminants, and that it is taking legal action against sellers.
The vendor disputes the connection. According to CBS, the vendor’s owner said by phone that the company does not sell retatrutide. The company’s attorney told CBS that the redacted report has no batch or lot number to check against company records, that the vial in the photo does not match the company’s current packaging, and that the FDA had not contacted the company. Whether the vial in the report came from this vendor has not been established, and these statements have not been verified.
Pieter Cohen, an associate professor at Harvard Medical School, told CBS the FDA should try to obtain and analyze the actual product each patient used, and said it would be a serious worry if the agency were not investigating vigorously.
What the FDA tells consumers
The FDA tells consumers not to buy products labeled for research purposes or not for human consumption, warning that quality is unknown and that illegally sold products may be counterfeit or contain the wrong or harmful ingredients, or too much, too little or none of the active ingredient. The agency says approved weight-loss medicines should be obtained with a prescription and filled at a state-licensed pharmacy. It lists deep discounts, label spelling errors and the absence of screening by a licensed doctor among the red flags. It also advises against using injectable GLP-1 drugs that arrive warm or insufficiently refrigerated, and says to use a new sterile needle and syringe for every dose.
Problems can be reported to the FDA through MedWatch, its program for reports of problems with medicines, online or by fax to 1-800-FDA-0178. Questions about drug information can go to the Center for Drug Evaluation and Research’s Office of Drug Information at 855-543-3784.
What retatrutide is, and where it stands
Retatrutide is an investigational drug from Eli Lilly. The FDA has not approved it. Lilly says it plans to submit an application to the FDA in the first quarter of 2027, and its July 23, 2026 release, as republished by BioSpace, states that the molecule cannot be legally sold or marketed for human use.
In that release, Lilly reported results from two phase 3 trials, TRIUMPH-2 and TRIUMPH-3. The most common side effects it listed were gastrointestinal, such as nausea, diarrhea, constipation and vomiting, along with an abnormal skin sensation called dysesthesia. The release said that in TRIUMPH-3, 9.8 percent of people taking 9 milligrams and 13.5 percent of those taking 12 milligrams stopped treatment because of adverse events, against 4.8 percent on placebo.
The release also addressed heart events. It said major adverse cardiovascular events, a trial composite of heart attack, stroke and cardiovascular death, occurred less frequently than anticipated in both the retatrutide and placebo groups. It reported exploratory hazard ratios of 1.12 for a three-part version of that composite (95 percent confidence interval 0.64 to 1.96; 27 events against 23) and 0.82 for a five-part version (0.55 to 1.22; 44 events against 52). Both intervals include 1, so the figures do not show a difference in either direction. The release gives no data on heart rhythm or heart rate. Trial results do not describe unregulated vials sold online and do not address the circumstances of the two reports.
Why people seek the drug
Lilly reported in the same release that in TRIUMPH-3, people with severe obesity and established cardiovascular disease lost about 21.6 percent of body weight on 9 milligrams and 22.6 percent on 12 milligrams at 80 weeks, against 3.2 percent on placebo, by the efficacy estimand, which counts people who stayed on treatment. Results like these are why demand exists. No legal retail channel exists, because the drug is unapproved and the FDA says it cannot be compounded, which means prepared as a customized drug by a pharmacy or outsourcing facility.
Why unapproved vials are sold
Sellers commonly label vials as for research use only or not for human consumption while their websites market dosing guides, calculators and supplies, according to FDA warning letters and Public Citizen. The FDA says that a research label does not change a product’s status as a drug when the seller’s materials point to human use. Public Citizen also said hundreds of influencers act as affiliates for such sellers, which is the group’s characterization.
In a separate CBS story updated July 2, 2026, a CBS reporter bought a vial billed as retatrutide for about $95 at a Brooklyn shop with no age check or prescription. The certificate of analysis that came with it appeared to show tirzepatide, a different drug, and the laboratory named on it said the reports attributed to it were fake.
The FDA’s position and enforcement
An FDA page, current as of Oct. 1, 2026, says retatrutide cannot be used in compounding under federal law. It says retatrutide is not a component of any FDA-approved drug and has not been found safe and effective for any condition. The agency says it has sent warning letters to telehealth companies marketing the drug, to distributors selling the active ingredient to compounders, and to outsourcing facilities repackaging it. The page’s adverse-event counts concern compounded semaglutide, with 990 reports as of May 31, 2026, and compounded tirzepatide, with more than 730. It also says it is likely that adverse events from compounded versions of these drugs are underreported, because state-licensed pharmacies that are not outsourcing facilities are not required to report them. That concerns compounded products, not research-labeled vials.
The FDA has also sent warning letters to online sellers of peptides, short chains of amino acids that some sellers market as research products. One letter, dated Sept. 9, 2025, concerned a seller of compounded retatrutide. Letters to sellers of research-labeled products that name retatrutide include one dated March 31, 2026, and several dated Aug. 24, 2026. No report ties any recipient of these letters to either death.
Public Citizen said in a June 16 news release that the FDA had sent 14 warning letters to retatrutide sellers since 2024, a count that predates the August letters, and that reports to the FDA as of June named retatrutide in at least 14 hospitalizations, which do not establish that the drug caused them. The release did not mention deaths. It also said the FDA showed little sign of moving to tougher sanctions, which is the group’s characterization.
Lilly announced six lawsuits on Aug. 12, 2026 against sellers it says marketed unapproved retatrutide, including online peptide sellers, a medical spa and a compounding pharmacy. Healio, citing Lilly, reported that the company has referred more than 200 individuals and entities to the FDA, the Department of Justice and other authorities and flagged more than 14,000 websites, ads and listings. As of about 10:15 a.m. EDT on Tuesday, Oct. 13, no ruling or settlement in the suits had appeared in coverage, and coverage did not show a federal criminal case aimed at retatrutide sellers. Lilly’s civil suits are the enforcement CBS describes.
Poison center exposure counts
America’s Poison Centers, a nonprofit, began tracking retatrutide exposures in late 2025. According to CBS, it logged 249 exposures in the first three months of 2026, 460 in the following three months and 862 in the three months ending in September. CBS noted that increases like this are common for a newly monitored drug. An exposure is a report of contact with a substance. It is not a death, and the count does not by itself say how many people were harmed.
What happens next
The FDA has not said whether it is investigating either case, and it generally does not discuss potential or ongoing compliance matters. Laboratory analysis of the products involved, a medical examiner’s findings, or any agency action tied to these reports would change what can be said about them, and none had been reported as of the morning of Oct. 13.