FDA record · warning letter

FDA warning letter: Eli Lilly and Company (Sep 9, 2025)

On Sep 9, 2025, FDA issued a warning letter to Eli Lilly and Company of Indianapolis, IN under the subject "False & Misleading Claims/Misbranded". It names tirzepatide. Open: no closeout letter published as of Oct 3, 2026.

Julian CaraulaniFounder, PriceTracker GLP-1FDA record read Oct 3

Status: Open: no closeout letter published as of Oct 3, 2026.

What FDA’s record states

FDA record for the warning letter to Eli Lilly and Company
Field	What FDA’s record states	Source
Recipient	Eli Lilly and Company	FDA letter
Location	Indianapolis, IN	FDA letter
Letter date	Sep 9, 2025	FDA letter
Posted by FDA	Sep 16, 2025	FDA index
Issuing office	Center for Drug Evaluation and Research (CDER)	FDA letter
Subject	False & Misleading Claims/Misbranded	FDA letter
MARCS-CMS number	716475	FDA letter
GLP-1 drugs named	Tirzepatide	FDA letter
Response letter	Not published by FDA	FDA letter
Closeout letter	Not published by FDA	FDA letter

“Food and Drug Administration (FDA) has reviewed the promotional communication, a direct-to-consumer online video (video) of an interview featuring representatives from Eli Lilly and Company (Eli Lilly) and a corresponding reporter asking questions regarding ZEPBOUND® (tirzepatide) injection, for subcutaneous use (Zepbound) posted on the website dayton247now.com.”FDA warning letter to Eli Lilly and Company, Sep 9, 2025 · read the full letter on fda.gov ↗

What this is and is not.A warning letter is FDA’s statement of what it considers significant violations. It is an allegation, not a court finding, and the firm can respond. A closeout letter is posted when FDA confirms the violations were corrected.

Other GLP-1 letters FDA issued that week

And 48 more in the full list.

Source

Every field above is copied from FDA’s page for this letter, read Oct 3, 2026. The letter on fda.gov ↗ · All 161 GLP-1 warning letters