If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
Zepbound ® (tirzepatide) injection
2.5 mg/ 5 mg/ 7.5 mg/ 10 mg/ 12.5 mg/ 15 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What are the health risks of using compounded tirzepatide?
Products claiming to be compounded tirzepatide, Mounjaro®, or Zepbound® are not subject to FDA approval, may not have the same safety, quality, and efficacy as FDA-approved drugs, and may expose patients to potentially serious health risks.
See important safety information, including boxed warning, in the attached prescribing information.
What are the Health Risks of Using Compounded Tirzepatide?
Eli Lilly and Company (Lilly) is the only lawful supplier of FDA-approved tirzepatide medicines–Mounjaro® and Zepbound®–and does not provide tirzepatide (the active ingredient in Mounjaro® and Zepbound®) to compounding pharmacies, med-spas, wellness centers, online retailers, or other manufacturers.1
Lilly does not know where compounding pharmacies or other sellers are obtaining the tirzepatide active ingredient they are selling.1
Compounded versions of tirzepatide can put people at risk. Sterility is a critical safety concern, given that Mounjaro® and Zepbound® are administered via under-the-skin injection.1
Lilly has discovered compounded drugs advertised as tirzepatide with safety, sterility, and efficacy problems. Some have contained bacteria, high impurity levels, different colors (eg, pink instead of colorless), or a completely different chemical structure than Lilly’s FDA-approved medicines. In at least one instance, the product was nothing more than sugar alcohol.1
For more information on counterfeit or compounded tirzepatide, you may visit https://www.lilly.com/safety/real-medicine.2
Enclosed Prescribing Information
Reference
1An open letter from Eli Lilly and Company regarding certain practices related to Mounjaro® (tirzepatide) and Zepbound® (tirzepatide). Press release. Eli Lilly and Company; June 20, 2024. Accessed June 20, 2024. https://investor.lilly.com/news-releases/news-release-details/open-letter-eli-lilly-and-company-regarding-certain-practices
2Protect yourself against counterfeit, fake, and unsafe or untested compounded products. Eli Lilly and Company. Accessed July 17, 2024. https://www.lilly.com/safety/real-medicine
Date of Last Review: July 17, 2024