FDA record · warning letter

FDA warning letter: Novo Nordisk Inc. (Mar 5, 2026)

On Mar 5, 2026, FDA issued a warning letter to Novo Nordisk Inc. of Plainsboro, NJ under the subject "Postmarketing Adverse Drug Experience Reporting Requirements". It names semaglutide, liraglutide. 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 Novo Nordisk Inc.
Field	What FDA’s record states	Source
Recipient	Novo Nordisk Inc.	FDA letter
Location	Plainsboro, NJ	FDA letter
Letter date	Mar 5, 2026	FDA letter
Posted by FDA	Mar 10, 2026	FDA index
Issuing office	Center for Drug Evaluation and Research (CDER)	FDA letter
Subject	Postmarketing Adverse Drug Experience Reporting Requirements	FDA letter
MARCS-CMS number	717576	FDA letter
GLP-1 drugs named	Semaglutide, Liraglutide	FDA letter
Response letter	Not published by FDA	FDA letter
Closeout letter	Not published by FDA	FDA letter

“As an application holder of products with active ingredients including semaglutide, liraglutide, nedosiran sodium, and estradiol, NNI is required to develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences (ADEs) to FDA.”FDA warning letter to Novo Nordisk Inc., Mar 5, 2026 · 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.

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