Lilly files its first round of lawsuits over products sold as tirzepatide

In September 2023, Eli Lilly filed the first in a series of lawsuits against med-spas, wellness centers, and other sellers marketing compounded products as tirzepatide, the active ingredient in its FDA-approved drugs Mounjaro and Zepbound ^[1]. More lawsuits followed in October 2023, opening a legal campaign that Lilly says has continued since ^[1].

Lilly's court filings allege that defendants misled consumers in three specific ways: by referring to their compounded products as Mounjaro or Zepbound or as equivalent to those brands, by citing results from Lilly's own clinical trials as if the compounded drugs had been part of those trials, and by referencing FDA approvals for Mounjaro and Zepbound as though the compounded versions were also FDA-approved ^[1]. None of the compounded products Lilly targeted have gone through FDA approval ^[1].

The company has said its testing found serious problems with some products sold as tirzepatide. Lilly reported finding bacteria, high impurity levels, colors that did not match its genuine colorless medicine (including pink), and chemical structures entirely different from its approved drugs ^[1]. In at least one case, Lilly said, a product advertised as tirzepatide turned out to be nothing more than sugar alcohol ^[1]. Lilly also flagged compounded pill or oral versions of tirzepatide being sold by some online pharmacies, noting that the FDA has approved tirzepatide only for injection under the skin and that no regulator has evaluated an oral version for safety or effectiveness ^[1].

The legal campaign has produced at least one public settlement. In May 2024, Lilly reached an agreement with Totality Medispa requiring a monetary payment and barring the company from advertising in ways that misled consumers into thinking its products were Lilly's Mounjaro or Zepbound, or an FDA-approved alternative ^[1]. Lilly said it reached similar settlements with other med-spas and wellness centers that had used its trademarks or made false claims about FDA approval ^[1].

Why it matters for patients

Compounded products sold under the tirzepatide name are not reviewed by the FDA the same way Mounjaro and Zepbound are, and the agency has said compounded drugs carry higher risk than approved medicines because they lack the same safety, quality, and effectiveness checks ^[1]. The National Association of Boards of Pharmacy has said illegal sellers are exploiting high demand and past shortages of these medicines to sell substandard or falsified products, putting patients at risk ^[1]. For someone buying a product marketed as tirzepatide from a med-spa or website, Lilly's findings suggest the contents may not match what is advertised, may be contaminated, or in rare cases may contain no active drug at all ^[1]. Lilly has also emphasized that Mounjaro and Zepbound are approved only for adults with specific medical conditions, not for cosmetic weight loss or for anyone under 18 ^[1].

What happens next

Lilly's legal campaign, which began with lawsuits filed in September and October 2023, continued into 2024. In June 2024, the company filed additional lawsuits against med-spas and wellness centers and published an open letter to patients and providers detailing its safety concerns about counterfeit and compounded products ^[1]. The sources reviewed here do not describe further settlements, court rulings, or the current status of any specific pending case beyond the May 2024 Totality Medispa agreement ^[1]. It is not yet known from available sources how many total lawsuits Lilly has filed since September 2023 or what has happened in cases that have not settled.