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Protect yourself from counterfeit and unsafe, mass compounded products
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Protect Yourself Against Counterfeit, Fake, and Unsafe or Untested Compounded Products

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The risks of counterfeit and compounded medicine

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As a medicine company, we believe that everyone who needs medicine deserves real medicine. That’s why we make medicine that is clinically tested and evaluated by regulators for safety and effectiveness.

In today’s society, health is a top concern, yet many discussions center on unproven products and treatments that claim to be alternatives to real medicine. These products are being mass-marketed and sold online, through social media, at certain med-spas, compounding pharmacies and wellness centers, and they put people at risk.

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Check the authenticity of your medicine
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https://scan.lilly.com
Check the authenticity of your medicine
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Types of inauthentic medicine

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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 medicine.
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01
Counterfeit / Fake products
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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.
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Counterfeit products are often advertised and sold online, through social media or at certain med-spas.

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Compounded products
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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.
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Pill organizer on a table next to a glass of water
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Mass compounding of tirzepatide must stop

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On March 5, a federal court confirmed that compounders, telehealth companies, med-spas, and everyone else “must cease production” of knockoffs of Lilly’s FDA-approved tirzepatide medicines.

Anyone continuing to sell mass compounded tirzepatide products, including by referring to them as “personalized,” “tailored” or something similar, is breaking the law and putting patient safety at risk.
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Learn about the dangers of mass compounding
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https://www.lilly.com
https://delivery-p137454-e1438138.adobeaemcloud.com/adobe/assets/urn:aaid:aem:d704c0fb-f176-4f05-9d6f-8f50290822d5/renditions/original/as/Mass_Compounding.pdf?assetname=Mass_Compounding.pdf
Mass compounding of Tirzepatide is dangerous and illegal infographic.
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A higher standard
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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."
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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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https://delivery-p137454-e1438138.adobeaemcloud.com/adobe/assets/urn:aaid:aem:ff1c7b3b-ae6d-4f32-ad94-d134310a2240/play?assetname=Lilly%20Manufacturing%20Main%20Video%20Captions%20Final.mp4

[00.00]

[MUSIC PLAYING]

[Text appears that says, Lilly, A Medicine Company.]

[00:04-00:06]

[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.

[00:07-00:09]

[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…

[00:10-00:14]

[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.

[00:15-00:16]

[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…

[00:17-00:19]

[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…

[00:20-00:30]

[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.

[00:31]

[Music playing. A red and white background fades on and off the screen.]

[00:32-00:34]

[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…

[00:35-00:39]

[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…

[00:40-00:49]

[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…

[00:50-00:52]

[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.

[00:53]

[Music playing and a red and white background fades on and off the screen.]

[00:54-00:58]

[Stainless-steel manufacturing equipment making medicines.]

Narrator: Lilly also carefully inspects its medicines before they ever leave its facilities.

[00:59-01:17]

[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.

[01:18-01:21]

[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,

[01:22-01:25]

[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.

[01:26-01:30]

[Music playing.]

[Industrial complex fades and the Lilly, A Medicine Company logo appears with a red background.]

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LillyDirect®

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One way to ensure you’re receiving genuine Lilly medicine is by using LillyDirect®. Through this service, if you have a valid prescription, you can get certain authentic Lilly medicines delivered directly to you—regardless of the healthcare provider you use.
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Learn More
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/lillydirect
Learn more about LillyDirect
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Recent news
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Explore the latest news on counterfeit and compounded medicine.
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Videos

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abc news

FBI Gives New Warning About Fake Weight Loss Drugs

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2025-03-14T00:00:00.000Z
Watch now
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https://www.wsbtv.com/news/local/atlanta/fbi-gives-new-warning-about-fake-weight-loss-drugs-being-sold-georgia/EZHFSSELPJAGLDMT4KCCQ7O4HU/
Watch the ABC segment "FBI Gives New Warning About Fake Weight Loss Drugs"
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cbs news

CBS Mornings: What Possible Compounded Semaglutide Ban Means for Patients

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2024-02-27T00:00:00.000Z
Watch now
link
https://www.cbsnews.com/video/what-possible-compounded-semaglutide-ban-means-for-patients/
Watch the video: What Possible Compounded Semaglutide Ban Means for Patients
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abc news

Shot in the Dark: Weight Loss Injection Wars

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2024-11-26T00:00:00.000Z
Watch now
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https://www.goodmorningamerica.com/video/116219628
Watch Shot in the Dark: Weight Loss Injection Wars
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cnbc

Ozempic Underworld – The Black Market of Weight Loss Drugs

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2024-10-09T00:00:00.000Z
Watch now
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https://www.youtube.com/watch?v=KfAPQ50V_ac
Watch Ozempic Underworld – The Black Market of Weight Loss Drugs
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abc news

Good Morning America on Lilly's fight against counterfeit drugs

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2024-10-03T00:00:00.000Z
Watch now
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https://abcnews.go.com/GMA/Wellness/video/inside-eli-lillys-fight-counterfeit-drugs-114461750
Watch Good Morning America on Lilly's fight against counterfeit drugs
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nbc nightly news

WHO issues warning about fake weight-loss drugs

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2024-06-20T00:00:00.000Z
Watch now
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https://www.youtube.com/watch?v=IhWYYTGbLAk
Watch: WHO issues warning about fake weight-loss drugs
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Articles

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Sun Sentinel

“The illicit trade in weight-loss drugs deserves a crackdown | Opinion”

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2025-09-16T00:00:00.000Z
Read more
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https://www.sun-sentinel.com/2025/09/16/the-illicit-trade-in-weight-loss-drugs-deserves-a-crackdown-opinion/?share=cn52iuaaspsosilunvsg
Read article: “The illicit trade in weight-loss drugs deserves a crackdown | Opinion”
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Real Clear Health

“The Price Patients Pay for Regulatory Neglect”

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2025-07-25T00:00:00.000Z
Read more
link
https://www.realclearhealth.com/articles/2025/07/25/the_price_patients_pay_for_regulatory_neglect_1124940.html
Read article: “The Price Patients Pay for Regulatory Neglect”
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The Tennessean

“Fake weight loss drugs spark alarm: Warning sent to FDA, FTS over counterfeit GLP-1s”

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2025-07-17T00:00:00.000Z
Read more
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https://www.tennessean.com/story/news/health/2025/07/17/fake-glp-1-wegovy-ozempic-concerns-fda/85257079007/?gnt-cfr=1&gca-cat=p&gca-uir=false&gca-epti=z115454p117950c117950u003154e002800v115454&gca-ft=258&gca-ds=sophi&sltsgmt=0154_C
Read article: “Fake weight loss drugs spark alarm: Warning sent to FDA, FTS over counterfeit GLP-1s”
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The Denver Post

“Colorado med spa recalls weight-loss and vitamin injections because of unsterile conditions”

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2025-07-15T00:00:00.000Z
Read more
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https://www.denverpost.com/2025/07/15/thrive-health-solutions-med-spa-recalls-weight-loss-drugs/
Read article: “Colorado med spa recalls weight-loss and vitamin injections because of unsterile conditions”
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Houston chronicle

“Empower Pharmacy Says It Sells 'Quality' Compounded Drugs. 10 Years Of FDA Violations Raise Doubts”

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2025-05-12T00:00:00.000Z
Read more
link
https://www.houstonchronicle.com/news/investigations/article/empower-pharmacy-compounded-drugs-fda-20281795.php
Read article: “Empower Pharmacy Says It Sells 'Quality' Compounded Drugs. 10 Years Of FDA Violations Raise Doubts”
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beckers hospital review

“FDA Warns GLP-1 Compounder Over Safety Rules”

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2025-01-30T00:00:00.000Z
Read more
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https://www.beckershospitalreview.com/pharmacy/fda-warns-glp-1-compounder-over-safety-rules.html
Read article: “FDA Warns GLP-1 Compounder Over Safety Rules”
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ohio capital journal

“Two Ohio doctors and their clinics disciplined over weight loss drugs”

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2025-01-28T00:00:00.000Z
Read more
link
https://ohiocapitaljournal.com/2025/01/28/two-ohio-doctors-and-their-clinics-disciplined-over-weight-loss-drugs/
Read article: “Two Ohio doctors and their clinics disciplined over weight loss drugs”
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reuters

“E-sellers of compounded weight-loss drugs fail to reveal risks, research shows”

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2025-01-17T00:00:00.000Z
Read more
link
https://www.reuters.com/business/healthcare-pharmaceuticals/websites-selling-compounded-weight-loss-drugs-fail-inform-patients-risks-2025-01-17/
Read article: “E-sellers of compounded weight-loss drugs fail to reveal risks, research shows”
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CNBC

“The Weight-Loss Drug Boom Has Become One of the Internet's Biggest Scams"

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2024-12-08T00:00:00.000Z
Read more
link
https://www.cnbc.com/2024/12/08/weight-loss-drug-boom-internets-biggest-scam.html
Read article: “The Weight-Loss Drug Boom Has Become One of the Internet's Biggest Scams"
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reuters

“US FDA Warns Against California Facility Making Compounded Weight-Loss Drugs"

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2024-11-01T00:00:00.000Z
Read more
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https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-warns-against-california-facility-making-compounded-weight-loss-drugs-2024-11-01/#:~:text=But%20the%20FDA%20has%20previously,risks,%20according%20to%20the%20FDA.
Read article: “US FDA Warns Against California Facility Making Compounded Weight-Loss Drugs"
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FAQs and resources
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What are the risks of compounded products?
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  • A recent analysis by researchers at Binghamton University found that compounded GLP-1s were nearly 2.5 times likely to result in hospitalization compared to FDA-approved GLP-1 medicines.
  • FDA’s most recent Report on the State of Pharmaceutical Quality found that 72% of the facilities manufacturing pharmaceutical ingredients that have been cited for regulatory violations by the FDA were sites that exclusively supply compounding pharmacies, even though those facilities represent only 18% of the total number of facilities registered with FDA. The FDA called attention to this “concerning trend” at these “higher risk sites,” noting that compounding pharmacies might not test their ingredients prior to using them to compound drugs.
  • According to the Obesity Action Coalition, “using a compounded medication is like playing a guessing game with your health. You don’t know what you’re getting, and if something goes wrong, it’s hard to know why.”
  • The FDA has explained that “poor compounding practices can result in serious drug quality problems, such as contamination,” which “can lead to serious patient injury and death.” The FDA has also observed “troubling conditions during many of its inspections of compounding facilities including toaster ovens used for sterilization, pet beds near sterile compounding areas, and operators handling sterile drug products with exposed skin, which sheds particles and bacteria, among many others.”
  • The National Capital Poison Control warns that “there can be errors in compounding or contamination of the product because compounding pharmacies are not held to the same standards of larger drug manufacturers.”
  • FDA published an alert on October 2, 2024, expressing its “concerns with unapproved GLP-1 drugs used for weight loss.” The alert covered a number of concerns with these products, which FDA called “risky for patients,” including counterfeit, non-human grade, and unsafe compounded versions, as well as dosing errors and adverse events, sometimes serious, from unapproved tirzepatide and other anti-obesity medications.
  • A recent report from Partnership for Safe Medicines found “suspicious, unauthorized, and illegal ingredients for popular diabetes and obesity injectables (commonly known as weight loss drugs) are flooding into the U.S. from foreign sources despite U.S. laws forbidding them from coming through the border.” According to PSM, these illicit ingredients are “entering the U.S. in large numbers bound for use in compounded and counterfeit products” where they put unsuspecting patients at risk of serious injury.
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What are the risks of counterfeit or fake products?
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  • Counterfeit or fake products are never safe to use. If you purchase them, you will have no way of knowing what ingredients they actually contain.
  • If you take counterfeit or fake medicine, you are rolling the dice with your health. The product may not only fail to treat your condition—it could cause you serious harm.
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How significant of a problem is counterfeiting?
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  • Unfortunately, the counterfeiting business is growing. Global criminal networks produce and distribute counterfeits in all major therapeutic areas, in all major geographies and in more than 100 countries. Skirting legal safeguards is big business: counterfeit product sales are estimated to generate between $200 billion and $431 billion in illicit proceeds every year.
  • According to an article on the FDA website, the National Association of Boards of Pharmacy (NABP) reports that at any given time, there are roughly 35,000 active online pharmacies – only about 5% of which comply with U.S. pharmacy laws and practice standards. The NABP reports that many are tied to criminal groups: “Most illegal internet pharmacies belong to organized criminal networks, many of which have been the recipients of FDA warning letters. These networks are often complex, global operations that include hundreds – or even thousands – of related websites.”
  • Illegal entities are engaging in phishing scams across the internet, phones and social media, claiming to sell weight loss medicines without a prescription. Often, these scammers never deliver anything – they simply pocket your money. Many also steal personal and financial information and use it to commit identity theft later on. Those that do deliver a product don’t provide genuine, FDA-approved medications. Instead, people receive fake or counterfeit products, such as an injection pen filled with insulin or saline or some completely unknown product – all of which may pose potentially serious health risks.
    • In the first four months of 2024, the online security firm McAfee found a 183% increase in phishing attempts centered on GLP-1s – 176,871 phishing attempts and 449 risky websites.
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How do I know if my medicine is counterfeit or fake?
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  • Counterfeit or fake products are mainly promoted and sold over the internet. This is one reason it’s important to obtain a prescription from your doctor and purchase prescription medicine from a pharmacy you are familiar with. LillyDirect® offers a medicine delivery service for select prescribed Lilly medicines.
  • Counterfeit or fake products may look very similar to genuine Lilly medicines. Knowing what genuine Lilly medicines look like can help you avoid purchasing or using counterfeit products. Visit the Lilly Medicine Verification Web App for more information.
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Common questions about counterfeit Mounjaro® and Zepbound® and compounded tirzepatide

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Is there evidence of unsafe or untested compounded tirzepatide?
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  • We have discovered compounded drugs advertised as "tirzepatide" with safety, sterility and efficacy problems. Some have contained bacteria, high impurity levels, different colors (pink, instead of colorless), or a completely different chemical structure than Lilly’s FDA-approved medicines. In at least one instance, the product being offered was nothing more than sugar alcohol.
  • Some telehealth providers and compounders are mass marketing untested forms of “tirzepatide” products online, including pill, under-the-tongue (sublingual), and nasal spray versions. It’s important to keep in mind that those formulations were not studied in the clinical trials that led to the FDA’s approval of Mounjaro® or Zepbound®, which are approved only for use via under-the-skin injection. That means the FDA has not evaluated or determined that any oral, sublingual or nasal versions of tirzepatide are safe or effective. If you purchase these untested versions, you may get a product that doesn’t work.
  • On May 21, 2024, the Australian government announced a complete ban on compounded tirzepatide and other compounded diabetes and weight loss medications due to the “increasing reports of patients coming to harm from [compounded incretin medications] including the hospitalization of a patient in Australia due to a serious adverse event.”
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  • We have discovered compounded drugs advertised as "tirzepatide" with safety, sterility and efficacy problems. Some have contained bacteria, high impurity levels, different colors (pink, instead of colorless), or a completely different chemical structure than Lilly’s FDA-approved medicines. In at least one instance, the product being offered was nothing more than sugar alcohol.
  • Some telehealth providers and compounders are mass marketing untested forms of “tirzepatide” products online, including pill, under-the-tongue (sublingual), and nasal spray versions. It’s important to keep in mind that those formulations were not studied in the clinical trials that led to the FDA’s approval of Mounjaro® or Zepbound®, which are approved only for use via under-the-skin injection. That means the FDA has not evaluated or determined that any oral, sublingual or nasal versions of tirzepatide are safe or effective. If you purchase these untested versions, you may get a product that doesn’t work.
  • On May 21, 2024, the Australian government announced a complete ban on compounded tirzepatide and other compounded diabetes and weight loss medications due to the “increasing reports of patients coming to harm from [compounded incretin medications] including the hospitalization of a patient in Australia due to a serious adverse event.”
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Should I believe advertisements about compounded tirzepatide products?
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  • A May 2025 survey by National Consumers League found that ‘widespread advertising and extensive online disinformation about compounded GLP-1 drugs’ exposed consumers to ‘misleading claims and falsehoods that have influenced their views of the safety of compounded products,’ including over half of respondents who incorrectly believed compounded GLP-1s are FDA-approved and over 70% of respondents who incorrectly believed that compounded drugs must be tested and proven safe to be on the market.
  • According to a recent cross-sectional study published in JAMA Health Forum, websites that sell compounded GLP-1/GIP products "often partially informed and sometimes misinformed potential consumers." Most websites did not disclose that compounded GLP-1/GIP products were not FDA-approved, some incorrectly referred to their products as "generic," and some even falsely "suggested these drugs were FDA approved." In addition, many websites "provided limited safety information and unauthorized efficacy claims."
  • It's important to understand both the risks and benefits of a medication before taking it. That's why anyone who promotes the benefits of a prescription medicine must also disclose the risks posed by the product.
  • Online ads about compounded products may be inaccurate or misleading. Some online sellers of compounded "tirzepatide" promote the potential health benefits of their products (for example, stating they will lead to easy weight management) without disclosing any potential side effects or safety risks of their products. These same online sellers may also be making claims that their non-injection (e.g., oral, under the tongue, nasal spray) "tirzepatide" products are effective without any scientific research or testing to support those claims.
  • Online sellers of compounded "tirzepatide" also sometimes claim that their "tirzepatide" is manufactured in FDA-approved facilities. While the FDA has the authority to approve medications, it does not approve the facilities in which they are manufactured, and FDA regulations expressly prohibit anyone from making that claim precisely because it is "misleading and constitutes misbranding."
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  • According to a recent cross-sectional study published in JAMA Health Forum, websites that sell compounded GLP-1/GIP products "often partially informed and sometimes misinformed potential consumers." Most websites did not disclose that compounded GLP-1/GIP products were not FDA-approved, some incorrectly referred to their products as "generic," and some even falsely "suggested these drugs were FDA approved." In addition, many websites "provided limited safety information and unauthorized efficacy claims."
  • It's important to understand both the risks and benefits of a medication before taking it. That's why anyone who promotes the benefits of a prescription medicine must also disclose the risks posed by the product.
  • Online ads about compounded products may be inaccurate or misleading. Some online sellers of compounded "tirzepatide" promote the potential health benefits of their products (for example, stating they will lead to easy weight management) without disclosing any potential side effects or safety risks of their products. These same online sellers may also be making claims that their non-injection (e.g., oral, under the tongue, nasal spray) "tirzepatide" products are effective without any scientific research or testing to support those claims.
  • Online sellers of compounded "tirzepatide" also sometimes claim that their "tirzepatide" is manufactured in FDA-approved facilities. While the FDA has the authority to approve medications, it does not approve the facilities in which they are manufactured, and FDA regulations expressly prohibit anyone from making that claim precisely because it is "misleading and constitutes misbranding."
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What is “research purposes only” tirzepatide?
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"Research purposes only" products are intended solely for scientific research—they should not be used or promoted for medical purposes. Nonetheless, some entities are promoting “tirzepatide” products for weight loss, even though they are labeled “research purposes only” and “not for human consumption.” These warnings indicate that the products have not been purified to pharmaceutical-grade levels and are not appropriate for human use. You should not use these products. They were not made by, studied by or sold by Lilly and they may expose you to significant health risks.
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"Research purposes only" products are intended solely for scientific research—they should not be used or promoted for medical purposes. Nonetheless, some entities are promoting “tirzepatide” products for weight loss, even though they are labeled “research purposes only” and “not for human consumption.” These warnings indicate that the products have not been purified to pharmaceutical-grade levels and are not appropriate for human use. You should not use these products. They were not made by, studied by or sold by Lilly and they may expose you to significant health risks.
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Is there evidence of counterfeit tirzepatide products?
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  • In August 2024, ProRx recalled over 3,200 vials of compounded tirzepatide (and about 12,000 vials of compounded semaglutide) due to a lack of assurances of sterility. In May 2025, Thrive Health and Wellness recalled over 1,300 syringes of compounded tirzepatide for the same reason.
  • The National Association of Boards of Pharmacy (NABP) – which includes State Boards of Pharmacy across all 50 U.S. states, the District of Columbia, Puerto Rico and many Canadian provinces – reported in May 2024 that “illegal actors are taking advantage of high demand and short supply [of incretin medications] in order to sell substandard and falsified versions of these products to patients around the world.” The NABP “has identified thousands of websites that promote the illegal sale of GLP-1 agonists,” including fake Mounjaro®, Zepbound®, and tirzepatide. Their “unlawful actions put patients at risk.”
  • On June 19, 2024, the World Health Organization issued a Medical Product Alert after identifying falsified batches of injectable incretin products in North America, South America and Europe.
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  • The National Association of Boards of Pharmacy (NABP) – which includes State Boards of Pharmacy across all 50 U.S. states, the District of Columbia, Puerto Rico and many Canadian provinces – reported in May 2024 that “illegal actors are taking advantage of high demand and short supply [of incretin medications] in order to sell substandard and falsified versions of these products to patients around the world.” The NABP “has identified thousands of websites that promote the illegal sale of GLP-1 agonists,” including fake Mounjaro®, Zepbound®, and tirzepatide. Their “unlawful actions put patients at risk.”
  • On June 19, 2024, the World Health Organization issued a Medical Product Alert after identifying falsified batches of injectable incretin products in North America, South America and Europe.
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How to report counterfeit products and adverse events.
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If you believe that you may have received or used counterfeit, fake or any otherwise unsafe versions of "tirzepatide", please contact your health care provider or seek immediate medical attention.
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Report locally
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You should also report any such products to local law enforcement, your state’s Board of Pharmacy or state poison control center.
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Call Lilly
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We also encourage anyone who believes they received or used counterfeit, fake, or any otherwise unsafe version of "tirzepatide" to contact the Lilly Answers Center at 1-800-LillyRx (1-800-545-5979).
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Contact the Lilly Answers Center at 1-800-LillyRx (1-800-545-5979)
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Ways we can help

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Reporting assistance
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We can assist you with reporting adverse events or other issues related to your receipt or use of counterfeit, fake or any otherwise unsafe versions of "tirzepatide".
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Find what you need
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We can help direct you to a supply of genuine Mounjaro® or Zepbound®.
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Save on medicine
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We can ensure you are aware of our savings card programs for Mounjaro® or Zepbound® for eligible, commercially insured patients.
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What we’re
doing about it
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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.
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Our commitment
to safety

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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.
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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.

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Our Stance
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Recent news from us about safe treatments.
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Lilly News Release

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2024-12-23T00:00:00.000Z
Lilly Commends ITC Ruling Cracking Down on the Unlawful Importation and Sale of Knock-Off Tirzepatide Products That Put Americans at Risk
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Read more
link
https://investor.lilly.com/news-releases/news-release-details/lilly-commends-itc-ruling-cracking-down-unlawful-importation-and
Read Lilly's news release on ITC ruling cracking down on the unlawful importation and sale of knock-off trizepatide
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Lilly News Release

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2024-06-20T00:00:00.000Z
Lilly Warns Patients About Counterfeit and Compounded Medicines Releases Open Letter and Takes Further Legal Action Against Counterfeit, Fake, Unsafe, and Untested Products
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Read more
link
https://investor.lilly.com/news-releases/news-release-details/lilly-warns-patients-about-counterfeit-and-compounded-medicines
Read Lilly News Release warning about counterfeit and compounded medicines
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Lilly News Release

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2024-05-14T00:00:00.000Z
Lilly Update on Mounjaro® and Zepbound® (tirzepatide) Compounding Litigation
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Read more
link
https://investor.lilly.com/news-releases/news-release-details/lilly-statement-mounjaror-tirzepatide-compounding-litigation
Read Lilly's update on Mounjaro® and Zepbound® (tirzepatide) Compounding Litigation
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Lilly News Release

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2024-03-07T00:00:00.000Z
Open Letter Regarding the Use of Mounjaro® (tirzepatide) and Zepbound® (tirzepatide)
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Read more
link
https://investor.lilly.com/news-releases/news-release-details/lilly-update-mounjaror-and-zepboundr-tirzepatide-compounding
Read Lilly's Open Letter Regarding the Use of Mounjaro® (tirzepatide) and Zepbound® (tirzepatide)
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Lilly News Release

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2023-09-13T00:00:00.000Z
Lilly Statement on Mounjaro® (tirzepatide) Compounding Litigation
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Read more
link
https://lilly.gcs-web.com/news-releases/news-release-details/open-letter-regarding-use-mounjaror-tirzepatide-and-zepboundr
Read Lilly Statement on Mounjaro® (tirzepatide) Compounding Litigation
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Regulator & public health reports
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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.
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U.S. Food & Drug Administration
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ProRx Warning Letter, March 4, 2025

FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize, U.S. Food & Drug Administration, December 19, 2024

FDA Warns Patients and Health Care Professionals Not To Use Compounded Drugs From Fullerton Wellness, U.S. Food & Drug Administration, November 1, 2024

FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, U.S. Food & Drug Administration, October 2, 2024

FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize, U.S. Food & Drug Administration, October 2, 2024

FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products, U.S. Food & Drug Administration, July 26, 2024

Counterfeit Medicine, U.S. Food & Drug Administration, 2024

Drug Compounding and Drug Shortages, U.S. Food & Drug Administration, 2023

Compounding and the FDA: Questions and Answers, U.S. Food & Drug Administration, 2022

New England Compounding Center Pharmacist Sentenced for Role in Nationwide Fungal Meningitis Outbreak, 2018

Owner and Four Former Employees of New England Compounding Center Convicted Following Trial, U.S. Food & Drug Administration, 2018

FDA Warning Letter to:

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FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize, U.S. Food & Drug Administration, December 19, 2024

FDA Warns Patients and Health Care Professionals Not To Use Compounded Drugs From Fullerton Wellness, U.S. Food & Drug Administration, November 1, 2024

FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, U.S. Food & Drug Administration, October 2, 2024

FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize, U.S. Food & Drug Administration, October 2, 2024

FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products, U.S. Food & Drug Administration, July 26, 2024

Counterfeit Medicine, U.S. Food & Drug Administration, 2024

Drug Compounding and Drug Shortages, U.S. Food & Drug Administration, 2023

Compounding and the FDA: Questions and Answers, U.S. Food & Drug Administration, 2022

New England Compounding Center Pharmacist Sentenced for Role in Nationwide Fungal Meningitis Outbreak, 2018

Owner and Four Former Employees of New England Compounding Center Convicted Following Trial, U.S. Food & Drug Administration, 2018

FDA Warning Letter to:

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State Regulators
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As Summer Approaches, AG Sunday Warns Pennsylvanians of Dangerous Counterfeit GLP-1 Drugs With Foreign Contents, Attorney General of the State of Pennsylvania, May 22, 2025

Attorney General Tong Sues GLP-1 Weight Loss Drug Distributor Triggered Brand, Announces Investigation Into Made In China Over Sale of Untested, Unsafe "Research-Grade" Drugs to Connecticut Consumers, Attorney General of the State of Connecticut, May 21, 2025

AG Fitch Warns Mississippians of Unapproved and Compounded Weight Loss Medications, Attorney General of the State of Mississippi, May 6, 2025

AG Yost Warns Med Spas: Stop Misleading Consumers About Weight-Loss Drugs, Attorney General of the State of Ohio, April 16, 2025

Press Release: 38 State and Territory Attorneys General Urge FDA to Take Action Against Counterfeit and Illegally Sold GLP-1 Drugs, February 19, 2025 (The full letter is available here)

Consumer Alert: Attorney General Alan Wilson Warns Consumers to be Cautious When Purchasing Unapproved and Compounded Weight Loss Medications, Attorney General of the State of South Carolina, January 3, 2025

Updated Consumer Alert: Attorney General Raoul Reminds Illinois Residents to be Vigilant When Seeking GLP-1 Drugs for Weight Loss, Attorney General of the State of Illinois, January 3, 2025

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Press Release: 38 State and Territory Attorneys General Urge FDA to Take Action Against Counterfeit and Illegally Sold GLP-1 Drugs, February 19, 2025 (The full letter is available here)

Consumer Alert: Attorney General Alan Wilson Warns Consumers to be Cautious When Purchasing Unapproved and Compounded Weight Loss Medications, Attorney General of the State of South Carolina, January 3, 2025

Updated Consumer Alert: Attorney General Raoul Reminds Illinois Residents to be Vigilant When Seeking GLP-1 Drugs for Weight Loss, Attorney General of the State of Illinois, January 3, 2025

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National Association of Boards of Pharmacy
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RogueRx Activity Report: Injectable Weight Loss Drugs: How Illegal Online Drug Sellers Are Taking Advantage of Patients, National Association of Boards of Pharmacy, 2024

Injectable Weight Loss Drugs Illegally Sold Online Pose Danger to Patients, National Association of Boards of Pharmacy, May 1, 2024

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RogueRx Activity Report: Injectable Weight Loss Drugs: How Illegal Online Drug Sellers Are Taking Advantage of Patients, National Association of Boards of Pharmacy, 2024

Injectable Weight Loss Drugs Illegally Sold Online Pose Danger to Patients, National Association of Boards of Pharmacy, May 1, 2024

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World Health Organization (WHO)
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Medical Product Alert N°2/2024, World Health Organization, June 19, 2024

Substandard and falsified medical products: Advice to patients and consumers, World Health Organization, December 9, 2019ding sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.

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Medical Product Alert N°2/2024, World Health Organization, June 19, 2024

Substandard and falsified medical products: Advice to patients and consumers, World Health Organization, December 9, 2019ding sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.

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Foreign Governments
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Warning about sharp rise in illegal medicines sold in the EU, European Medicines Agency, September 3, 2025

UK Medicines Regulator Warns Against Buying Weight Loss Medicines Without a Prescription This New Year, Government of the United Kingdom, Medicines and Healthcare Products Regulatory Agency (MHRA), December 30, 2024

HPRA Statement – RTÉ Investigates Report On Illegally Supplied GLP-1 Medicines Promoted As Weight Loss Products, Government of Ireland, Health Products Regulatory Authority (HPRA), December 9, 2024

SAHPRA’s Position On GLP1 And GIP-GLP1 Products That Are Compounded, Substandard And Falsified, Government of South Africa, South African Health Products Regulatory Authority (SAHPRA), November 8, 2024

MHRA Warns of Unsafe Fake Weight Loss Pens, Government of the United Kingdom, Medicines and Healthcare products Regulatory Agency (MHRA), October 26, 2024

Counterfeit Ozempic Pens Detected and Adverse Event Reported, Government of Australia, Department of Health & Aged Care, September 30, 2024

Protecting Australians From Unsafe Compounding of Replica Weight Loss Products, Government of Australia, Department of Health & Aged Care, May 22, 2024

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UK Medicines Regulator Warns Against Buying Weight Loss Medicines Without a Prescription This New Year, Government of the United Kingdom, Medicines and Healthcare Products Regulatory Agency (MHRA), December 30, 2024

HPRA Statement – RTÉ Investigates Report On Illegally Supplied GLP-1 Medicines Promoted As Weight Loss Products, Government of Ireland, Health Products Regulatory Authority (HPRA), December 9, 2024

SAHPRA’s Position On GLP1 And GIP-GLP1 Products That Are Compounded, Substandard And Falsified, Government of South Africa, South African Health Products Regulatory Authority (SAHPRA), November 8, 2024

MHRA Warns of Unsafe Fake Weight Loss Pens, Government of the United Kingdom, Medicines and Healthcare products Regulatory Agency (MHRA), October 26, 2024

Counterfeit Ozempic Pens Detected and Adverse Event Reported, Government of Australia, Department of Health & Aged Care, September 30, 2024

Protecting Australians From Unsafe Compounding of Replica Weight Loss Products, Government of Australia, Department of Health & Aged Care, May 22, 2024

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Poison Control Centers
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Maryland Poison Control, What You Should Know About Semaglutide, March 26, 2024

America’s Poison Centers, Glucagon-Like Peptide-1 (GLP-1) Agonists, June 2024

National Capital Poison Center, What is Ozempic?, December 2023

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Maryland Poison Control, What You Should Know About Semaglutide, March 26, 2024

America’s Poison Centers, Glucagon-Like Peptide-1 (GLP-1) Agonists, June 2024

National Capital Poison Center, What is Ozempic?, December 2023

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Partnership for Safe Medicines (PSM)
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Prescription Drug Freight Fraud Report, September 2025

What is a 503B outsourcing facility, and why are so many of them uninspected by FDA?, July 16, 2025

Knockoff Weight Loss Drugs From Illegal Foreign Sources: An analysis of unauthorized semaglutide and tirzepatide shipments entering the U.S. with urgent recommendations to protect the safety of Americans, February 20, 2025

Letter to FDA’s Office of Prescription Drug Promotion, CDER – Partnership for Safe Medicines, February 5, 2025

Letter to Fox Corporation regarding misleading Hims&Hers Super Bowl ad – Partnership for Safe Medicines, February 5, 2025

Counterfeit and compounded injected diabetes and obesity treatments — twin threats to American patients, Partnership for Safe Medicines, 2024

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Knockoff Weight Loss Drugs From Illegal Foreign Sources: An analysis of unauthorized semaglutide and tirzepatide shipments entering the U.S. with urgent recommendations to protect the safety of Americans, February 20, 2025

Letter to FDA’s Office of Prescription Drug Promotion, CDER – Partnership for Safe Medicines, February 5, 2025

Letter to Fox Corporation regarding misleading Hims&Hers Super Bowl ad – Partnership for Safe Medicines, February 5, 2025

Counterfeit and compounded injected diabetes and obesity treatments — twin threats to American patients, Partnership for Safe Medicines, 2024

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Drug Enforcement Agency (DEA)
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Public Safety Alert: DEA Issues Warning About Illegal Online Pharmacies, DEA, October 4, 2024
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Public Safety Alert: DEA Issues Warning About Illegal Online Pharmacies, DEA, October 4, 2024
Centers for Disease Control and Prevention (CDC)
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Potential public health risk among individuals ordering counterfeit prescription medications from online pharmacies, CDC, October 2, 2024
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Potential public health risk among individuals ordering counterfeit prescription medications from online pharmacies, CDC, October 2, 2024
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Patient advocacy groups

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Patient advocacy groups have also spoken out against counterfeit and compounded versions of "tirzepatide" given the risks these products pose to patients.
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Center for Medicine in the Public Interest

Myth or Fact: Mass Compounding

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2025-09-10T00:00:00.000Z
Read more
link
https://mr.cdn.ignitecdn.com/client_assets/cmpiorg/media/attachments/68bb/521e/b6a4/24ed/82c8/13b3/68bb521eb6a424ed82c813b3.pdf?1757106718
Read: Myth or Fact: Mass Compounding
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National Consumers League

Fraud, Counterfeits, and Unsafe Doses: NCL Sounds Alarm on Compound GLP-1 Market

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2025-09-05T00:00:00.000Z
Read more
link
https://nclnet.org/fraud-counterfeits-and-unsafe-doses-ncl-sounds-alarm-on-compounded-glp-1-market/
Read: Fraud, Counterfeits, and Unsafe Doses: NCL Sounds Alarm on Compound GLP-1 Market
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Center for Medicine in the Public Interest

FDA Regulatory Failures in Enforcing Limits on GLP-1 Compounding Puts Patients at Risk

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2025-07-21T00:00:00.000Z
Read more
link
https://cmpi.org/in-the-news/fda-regulatory-failures-in-enforcing-limits-on-glp-1-compounding-puts-patients-at-risk
Read: FDA Regulatory Failures in Enforcing Limits on GLP-1 Compounding Puts Patients at Risk
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National Consumers League

America's second obesity crisis is an infodemic of disinformation about GLP-1 weight loss drugs

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2025-05-01T00:00:00.000Z
Read more
link
https://nclnet.org/americas-second-obesity-crisis-is-an-infodemic-of-disinformation-about-glp-1-weight-loss-drugs/
Read: America's second obesity crisis is an infodemic of disinformation about GLP-1 weight loss drugs
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Obesity Action Coalition

Why OAC Warns Against Compounded GLP-1 Medications

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2025-03-24T00:00:00.000Z
Read more
link
https://www.obesityaction.org/why-oac-warns-against-compounded-glp-1-medications/
Read: Why OAC Warns Against Compounded GLP-1 Medications
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The Obesity Society

Obesity Action Coalition & The Obesity Society send letter to FDA on behalf of more than 20 leading organizations & providers urging enforcement of compounding regulations

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2025-03-21T00:00:00.000Z
Read more
link
https://www.eurekalert.org/news-releases/1077743
Read: Obesity Action Coalition & The Obesity Society send letter to FDA on behalf of more than 20 leading organizations & providers urging enforcement of compounding regulations
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The Obesity Society

The Obesity Society commends FDA's resolution of obesity drug shortages, calls for enforcement against unauthorized compounding

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2025-02-26T00:00:00.000Z
Read more
link
https://www.eurekalert.org/news-releases/1075075
Read: The Obesity Society commends FDA's resolution of obesity drug shortages, calls for enforcement against unauthorized compounding
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global healthy living foundation

Global Healthy Living Foundation Says Hims & Hers Health Super Bowl Ad Omits Risks of Weight Loss Drug – Urges Greater Transparency and Patient Protections, Global Healthy Living Foundation...

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2025-02-08T00:00:00.000Z
Read more
link
https://www.businesswire.com/news/home/20250208077324/en/Global-Healthy-Living-Foundation-Says-Hims-Hers-Health-Super-Bowl-Ad-Omits-Risks-of-Weight-Loss-Drug
read: Global Healthy Living Foundation Says Hims & Hers Health Super Bowl Ad Omits Risks of Weight Loss Drug...
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The Obesity Society

Ad perpetuates obesity stigma for patients in need of safe and effective medications

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2025-02-07T00:00:00.000Z
Read more
link
https://www.eurekalert.org/news-releases/1072956
Read: Ad perpetuates obesity stigma for patients in need of safe and effective medications
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national consumers league

NCL urges the public to heed warnings about unregulated versions of GLP-1 weight loss drugs

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2025-02-04T00:00:00.000Z
Read more
link
https://nclnet.org/the-national-consumers-league-urges-the-public-to-heed-warnings-about-unregulated-versions-of-glp-1-weight-loss-drugs/
Read: NCL urges the public to heed warnings about unregulated versions of GLP-1 weight loss drugs
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American Diabetes Association

The American Diabetes Association Announces Statement on Compounded Incretin Products

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2024-12-02T00:00:00.000Z
Read more
link
https://diabetes.org/newsroom/press-releases/american-diabetes-association-announces-statement-compounded-incretin#:~:text=The%20statement%20recommends%20against%20using,safety,%20quality,%20and%20effectiveness.
Read: The American Diabetes Association Announces Statement on Compounded Incretin Products
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Obesity Action Coalition

We Understand the Struggle: Why Compounded GLP-1 Medications Aren’t the Answer

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2024-05-31T00:00:00.000Z
Read more
link
https://www.obesityaction.org/why-compounded-glp-1-medications-arent-the-answer/
Read from the OAC: We Understand the Struggle: Why Compounded GLP-1 Medications Aren’t the Answer
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obesity medicine association

Obesity Medicine Association Issues a Position Statement on Compounded Peptides

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2024-03-30T00:00:00.000Z
Read more
link
https://obesitymedicine.org/blog/obesity-medicine-association-issues-a-position-statement-on-compounded-peptides/
Read: Obesity Medicine Association Issues a Position Statement on Compounded Peptides
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Obesity Action Coalition

Obesity Care Organizations Issue Joint Statement: Do Not Use Compounded Alternatives to GLP-1 Medications

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2024-01-09T00:00:00.000Z
Read more
link
https://www.obesityaction.org/obesity-care-organizations-issue-joint-statement-do-not-use-compounded-alternatives-to-glp-1-medications/
Read: Obesity Care Organizations Issue Joint Statement: Do Not Use Compounded Alternatives to GLP-1 Medications
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