Eli Lilly and Company

Warning LetterOpen

David A. Ricks Chief Executive Officer Eli Lilly and Company Lilly Corporate Center Indianapolis , IN 46285 United StatesFEI 3027403675Issued Sep 9, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3027403675.

Violations2

Issue DateSep 9, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Eli Lilly and Company
Location: David A. Ricks Chief Executive Officer Eli Lilly and Company Lilly Corporate Center Indianapolis , IN 46285 United States
FEI Number: 3027403675
Country: United States
Issue Date: September 09, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Eli Lilly distributed a false or misleading direct-to-consumer video promoting ZEPBOUND® (tirzepatide) that misrepresented the safety and effectiveness of the drug, which carries serious risks including a boxed warning for thyroid C-cell tumors. The company violated the Federal Food, Drug, and Cosmetic Act by failing to submit the promotional materials for FDA review prior to dissemination, as required by 21 CFR 314.81(b)(3)(i). The video, featuring company representatives and posted on a Fox25 affiliate website in July 2025, created a misleading impression about the drug's safety profile despite its multiple serious and potentially life-threatening risks.

Eli Lilly and Company FDA Warning Letter, September 9, 2025