
Protect Yourself Against Counterfeit, Fake, and Unsafe or Untested Compounded Products
The Risks of Counterfeit and Compounded Medicine
As a medicine company, we take product safety seriously. We want to make sure you have the information you need to protect yourself against counterfeit, fake, and unsafe or untested compounded knock-offs of Lilly medicines. Unfortunately, a growing number of these products are being mass-marketed and sold online, through social media and at certain med-spas, compounding pharmacies and wellness centers. They put people at risk.
Counterfeit / Fake Products: Counterfeit or fake products are made and sold in a manner that falsely represents their authenticity, origin or effectiveness. According to the FDA, counterfeit products “may contain the wrong ingredients, contain too much, too little or no active ingredient at all or contain other harmful ingredients.” They may also be made in unsanitary conditions by unregulated entities without adequate skill or training. Counterfeit products are often advertised and sold online, through social media or at certain med-spas.
Compounded Products: The Food and Drug Administration (FDA) defines drug compounding as the “process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient.” This practice is permitted in limited circumstances to address individual patient needs, such as making a medicine without a dye that a patient is allergic to. However, compounded products are never FDA-approved.
If you suspect you have received counterfeit or fake Lilly medicine, this resource can help verify your product.
A Higher Standard
At Lilly, we meet strict requirements set by the FDA and other global regulators. We’re held to far higher standards than compounding pharmacies, which is why the FDA cautions that "compounded drugs pose a higher risk to patients than FDA-approved drugs."
Learn more about Lilly’s use of state-of-the-art technologies that help ensure our medicines are safe and effective – including robotics, automation, and vigilant monitoring.
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[Text appears that says, Lilly, A Medicine Company.]
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[A white background with red and white medication icons appears on the screen and fade to a red Lilly logo.]
Narrator: Making medicines the Lilly way is not easy.
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[Two people wearing full protective gear appear on the screen, it then fades to a gold color liquid in a beaker, and a person wearing a blue lab coat and yellow gloves handles a pipette and a test tube.]
Narrator: Lilly's manufacturing sites comply with strict requirements…
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[A complex automated assembly line with robotic arms and mechanical components inside a transparent enclosure appears. Various wires and electronic components are connected to the machinery and then it fades to a person in full-body protective white clothing operating large stainless-steel tanks in a sterile industrial setting. The tanks are connected to various pipes and gauges.]
Narrator: …set by the FDA and other global regulators who inspect our facilities regularly.
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[Two people wearing full protective gear appear on the screen, looking at a control panel and white binder and working using a piece of complex manufacturing equipment. The image fades to an overview shot of the workers looking at the control panel and binder working.]
Narrator: We are held to much higher standards…
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[An arm with a purple glove is working on a piece of lab equipment with a cylindrical container with tubes and a filtration system. The FDA logo appears on the screen and a white box fades on the screen with a caution icon.]
Narrator: … than compounding pharmacies, which is why the FDA cautions…
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[The words "Compounded drugs pose a higher risk to patients than FDA-approved drugs, should only be used for patients whose medical needs cannot be met by an available FDA-approved drug." appear on the screen in the box.]
Narrator: …that compounded drugs pose a higher risk to patients than FDA-approved drugs and should only be used for patients whose medical needs cannot be met by an available FDA-approved drug.
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[A close-up of an automated conveyor system with vials or containers moving in a production line. The setup is metallic with high-tech precision equipment.]
Narrator: Our clean room facilities are run by highly skilled employees…
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[Two people wearing protective gear work behind a glass enclosure with machinery and gloves attached to ports. The screen fades to working machinery that has various metallic and plastic components, tubes, and instruments.]
Narrator: …using state of the art equipment. High precision robotics and automation…
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[Two large, enclosed, stainless-steel manufacturing machines inside a clean room. Transparent panels allow a view of the inner mechanisms, and the floor is bright blue. The screen fades to an enclosed stainless-steel manufacturing machine, showing a close-up of the machines filling medication syringes.]
Narrator: …ensure clean room environments that minimize the risk of contamination, and we vigilantly monitor our facilities, taking thousands of samples of air and surfaces…
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[Two people in full protective gear are working on enclosed manufacturing equipment that has holes to put your arms through. The words, "Quality that patients can count on." appear on the screen.]
Narrator: …to ensure our sterile products with the quality that patients can count on.
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[Music playing and a red and white background fades on and off the screen.]
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[Stainless-steel manufacturing equipment making medicines.]
Narrator: Lilly also carefully inspects its medicines before they ever leave its facilities.
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[A machine control panel with a touchscreen displays a syringe-like object. A person wearing safety gear stands in the background behind a glass barrier. Working manufacturing equipment taking images and producing medicines appears on the screen.]
Narrator: When Lilly's medicine is filled into sterile syringes, computers record and process thousands of pieces of information and take over 60 pictures of each individual syringe to ensure it has no imperfections that could cause harm, and we test more than 100 samples per batch to ensure that the end product is safe and effective.
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[A white background with a red Lilly logo and a timeline beginning in 1876 and moving from 2020 until today appears on the screen.]
Narrator: For over a century, we've said that if it bears a red Lilly,
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[A large industrial complex with multiple buildings surrounded by parking lots and roads. Trees line the perimeter, and several cars are parked in the lot. A main building with a modern glass façade stands at the front labeled, Lilly.]
Narrator: …it's right, and that continues to be true today.
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[Industrial complex fades and the Lilly, A Medicine Company logo appears with a red background.]
Recent News on Counterfeit and Compounded Medicine
FAQs and Resources
What We’re Doing About It
No single entity can stop counterfeiting and unsafe or untested compounded products. That’s why we’re partnering with global government regulatory and law enforcement agencies, along with other pharmaceutical companies, to deliver a global anti-counterfeiting strategy that prioritizes patient safety.
As part of our commitment to safety, we issued an open letter on June 20, 2024, to inform people living with diabetes and obesity, their families, and their health care providers about potentially serious risks posed by the proliferation of counterfeit, fake, and unsafe or untested compounded knock-offs of our FDA-approved tirzepatide medications (Mounjaro® and Zepbound®) and about appropriate use of our genuine medicines.
We also continue to support international educational efforts by non-governmental organizations such as the World Health Organization, Partnership for Safe Medicines and others to warn patients and health care professionals about the dangers of buying medicines from non-traditional outlets.
One way to ensure you’re receiving genuine Lilly medicine is by using LillyDirect™. Through this service, we can not only help connect you with a health care provider, but also help you get certain prescribed medicines delivered directly to you (regardless of the health care provider you use).
Our Stance
Recent news from us about safe treatments.
News Releases:
Regulator and Public Health Reports
Regulators and public health organizations, including the FDA, State Boards of Pharmacy, foreign governments, the World Health Organization and others have issued reports on counterfeit and compounded products. Many of those reports are linked below.
Patient Advocacy Groups
Patient advocacy groups have also spoken out against counterfeit and compounded versions of "tirzepatide" given the risks these products pose to patients.