FDA & regulation

Lilly moves against imports of counterfeit Mounjaro

A report of new Lilly lawsuits against pharmacies selling counterfeit Mounjaro could not be confirmed as of September 2026; the only available source describes an earlier, 2023 legal action.

By the Semaglutides news desk··Mounjaro

A trade-press item dated September 6, 2026, claimed that Eli Lilly had filed new lawsuits against pharmacies for importing counterfeit Mounjaro into the United States. As of a fact-check on September 14, 2026, that specific article could not be retrieved, and the claim has not been independently confirmed.

The only source available to verify this development is a 2023 Reuters report describing an earlier action. In October 2023, Eli Lilly sued 11 online pharmacies, asking the U.S. International Trade Commission to ban them from importing, selling, or distributing products that claimed to contain tirzepatide, the active ingredient in Mounjaro [1]. The named defendants included U.S.-based companies Artic Peptides, Strate Labs, Supopeptide, The Triggered Brand, and Unewlife, along with Britain's Biolabshop, Spain's Super Human Store, Poland's Steroide Kaufen, and China's Audrey Beauty, Mew Mews Company, and AustroPeptide [1].

Lilly said lab testing of one product, sold by AustroPeptide and marketed as containing tirzepatide, actually contained "nothing more than sugar alcohol" [1]. The company accused the pharmacies of trademark infringement, false association with Lilly and its approved tirzepatide products, and misleading advertising [1]. Lilly's complaint stated that "the unapproved drug products are dangerous research chemicals that are not approved for human consumption and have no connection to Eli Lilly or Mounjaro" [1].

That 2023 case followed a separate suit filed a month earlier against 10 U.S. medical spas, wellness centers, and compounding pharmacies in federal courts in Arizona, Florida, Georgia, Minnesota, South Carolina, and Utah, also over products claiming to contain tirzepatide [1]. Around the same time, the FDA published warning letters to two online vendors selling unapproved versions of tirzepatide and semaglutide, the active ingredient in Novo Nordisk's Ozempic and Wegovy [1]. Lilly is the only company with FDA approval to sell tirzepatide products in the United States [1].

It is not known from the available sources whether Lilly has filed any new lawsuits in 2026, what pharmacies might be named, or what products were tested. The gap between the 2026 headline and the 2023 source means readers should treat the September 2026 claim as unconfirmed until a verifiable report surfaces.

Why it matters for patients

Counterfeit or unapproved products sold under the Mounjaro name have shown up before with no real drug in them, as the 2023 testing of one product found only sugar alcohol instead of tirzepatide [1]. Patients who buy tirzepatide or semaglutide products from unverified online sellers, medical spas, or compounding operations outside the normal pharmacy system may not know what they are actually receiving. Legal actions like the 2023 ITC complaint and federal lawsuits are one tool regulators and manufacturers use to try to remove these products from the market, but such cases can take time to resolve, and the products named as defendants can change [1].

What happens next

Based on the confirmed 2023 case, an ITC complaint like the one filed that October would need to be published in the Federal Register, after which the commission has 30 days to decide whether to accept it [1]. It is not known from current sources whether any new 2026 action has been filed, accepted, or scheduled for review. Readers looking for updates should watch for a verifiable, dated report confirming any new Lilly lawsuit before treating the September 2026 claim as established fact.

Sources

  1. https://www.medscape.com/s/viewarticle/997553

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