FDA warning letter: Eli Lilly and Company
What the FDA told Eli Lilly and Company in September 2025 about tirzepatide — and whether it has been resolved.
“Ricks Recipient Title Chief Executive Officer Eli Lilly and Company Lilly Corporate Center Indianapolis , IN 46285 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States RE: NDA 217806 and 215866 ZEPBOUND® (tirzepatide) injection, for subcutaneous use MOUNJARO® (tirzepatide) injection, for subcutaneous use MA 974 and 832 W …”
What an FDA warning letter is
It is a letter. The FDA writes to a company to say which of its practices the agency believes break the law, and asks it to fix them. That is the whole mechanism: a written notice, published so anyone can read it.
It is the FDA’s position, not a court’s finding. The company can reply, and can disagree. The agency states in these letters that failing to address the problems may lead to further action such as seizure or an injunction — which tells you the letter itself is not yet either of those things.
A warning letter does not recall a product, suspend a licence or close a business. It does not mean that medicine already dispensed was unsafe. When the FDA is satisfied the problems are fixed, it publishes a closeout letter.
What it does tell you is that a regulator looked at this company and wanted something changed. The useful question is what — and the quoted passage above answers it more precisely than any summary can.
What the letter says
| Field | What the letter states | Source |
|---|---|---|
| Recipient | Eli Lilly and Company | FDA warning letter |
| Issued | Sep 9, 2025 | FDA warning letter |
| Issuing office | Center for Drug Evaluation and Research (CDER) | FDA warning letter |
| FDA reference | MARCS-CMS 716485 | FDA warning letter |
| Location | Indianapolis, IN, United States | FDA warning letter |
| Subject | False & Misleading Claims/Misbranded | FDA warning letter |
| What it concerns | What the website claimed | Read from the subject line |
| Medication named | Tirzepatide | Letter text |
| Status | Open — no closeout letter published | FDA warning letter list |
The FDA sent 8 other letters that day
These letters go out in waves rather than one at a time, so the rest of the wave is the context this one sits in.
- FDA warning lettersPublished compliance actions, updated weekly
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- FDA National Drug Code directoryLabeler, product and package listings
NADAC figures are pharmacy acquisition costs, not retail prices and not what you will pay. This content is educational and is not medical advice.