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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.
FDA Approved Medicines
Medicines in the United States are approved by the U.S. Food and Drug Administration (FDA) under new drug applications (NDAs) or abbreviated new drug applications (ANDA). Outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need. In this case, an exception to the law is reviewed by the FDA.1
Last year, 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. it is 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.2
The U.S. Food and Drug Administration (FDA) announced it is proposing to exclude tirzepatide and other non-Lilly medicines from the 503B bulks list finding no clinical need for the exception to outsourcing facilities to compound these drugs from bulk substances on April 30, 2026.1
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.3
What are the Health Risks of Using Compounded Tirzepatide?
Lilly does not know where compounding pharmacies or other sellers are obtaining the tirzepatide active ingredient they are selling.3
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.3
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.3
For more information on counterfeit or compounded tirzepatide, you may visit https://www.lilly.com/safety/real-medicine.2
Enclosed Prescribing Information
Reference
1List of bulk drug substances for which there is a clinical need under section 503B of the Federal Food, Drug, and Cosmetic Act: a notice from the Food and Drug Administration. Accessed May 13, 2026. Posted May 1, 2016. https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal
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
3An 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
Date of Last Review: May 13, 2026