Ozempic Maker Novo Nordisk Faces Another Strike By US FDA With Warning Letter Over 'Systemic Failures' In Safety Reporting

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Novo Nordisk A/S (NYSE:NVO), marking another regulatory strike on the pharmaceutical giant over the last six months following a pattern of safety and marketing lapses.

Systemic Failures In Safety Data

In a letter dated March 5, 2026, the FDA detailed "serious violations" regarding Novo Nordisk's postmarketing adverse drug experience (PADE) reporting.

The agency's inspection, conducted in early 2025, revealed that the maker of Ozempic and Wegovy failed to report serious and unexpected side effects—including patient deaths and strokes—within the mandatory 15-day window.

The FDA noted that these lapses were not merely clerical but suggested "systemic failures" in how the company and its third-party contractors conducted surveillance, evaluation, and reporting of safety data.

The agency expressed "serious concerns" that these violations could affect the company's entire product portfolio, including high-demand GLP-1 medications such as semaglutide.

Unreported Deaths And Strokes

One specific instance cited involved a patient who experienced a stroke while taking liraglutide. Novo Nordisk allegedly rejected the report because the patient believed the event was unrelated to the drug. However, FDA regulations state that any serious event must be reported "whether or not considered drug-related."

In another case involving semaglutide, the company failed to capture a patient identifier for a reported death, leading to the case being “erroneously” invalidated. The FDA emphasized that "accurate, reliable, and timely safety data" is essential to protecting public health.

Pattern Of Regulatory Lapses?

This latest warning follows a turbulent period for the Danish drugmaker. In September 2025, the FDA placed Novo on a “green list” import alert to curb unverified ingredients and issued separate warnings regarding “misleading” marketing claims made during high-profile media appearances.

The FDA has given Novo Nordisk 15 business days to provide a detailed plan to prevent future violations, warning that failure to do so "may lead to regulatory action."

NVO Underperforms In 2026

Shares of Novo Nordisk have declined 24.40% year-to-date, and it was down 28.78% over the last six months, and 50.96% over the year.

NVO maintains a weaker price trend over the short, medium, and long terms, with a solid quality score, as per Benzinga's Edge Stock Rankings.

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

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This article Ozempic Maker Novo Nordisk Faces Another Strike By US FDA With Warning Letter Over 'Systemic Failures' In Safety Reporting originally appeared on Benzinga.com