FDA Warns Maker of Ozempic, Wegovy Over Unreported Side Effects

The drugmaker Novo Nordisk failed to report potential deaths and other serious side effects in a timely manner, the FDA alleges.

Mar. 12, 2026 at 10:05pm

Got story updates? Submit your updates here. ›

The U.S. Food and Drug Administration has sent a warning letter to Novo Nordisk, the maker of the popular diabetes and weight loss medications Ozempic and Wegovy. The FDA alleges that Novo Nordisk failed to report potential side effects, including three deaths, in a timely manner as required. The pharmaceutical company acknowledged the warning letter and said it is working to address the concerns raised by the FDA.

Why it matters

The FDA's warning highlights the importance of drug manufacturers properly reporting any potential safety issues with their medications. Failure to do so can put patients at risk. This case also comes as demand for GLP-1 weight loss drugs like Ozempic and Wegovy has surged, leading to concerns about potential scams and counterfeit products.

The details

In the March 5 warning letter, the FDA noted it observed 'serious violations' during a Post-marketing Adverse Drug Experience inspection at Novo Nordisk's New Jersey site last year. The letter cited three deaths among patients who took semaglutide, the active ingredient in Ozempic and Wegovy, including one person who died by suicide. The FDA said Novo Nordisk did not report these deaths to the agency within the required timeframe.

  • The FDA inspection at Novo Nordisk's New Jersey site took place in early 2025.
  • The FDA issued the warning letter to Novo Nordisk on March 5, 2026.

The players

Novo Nordisk

A pharmaceutical company that manufactures the diabetes and weight loss medications Ozempic and Wegovy.

U.S. Food and Drug Administration (FDA)

The federal agency responsible for regulating and supervising the safety of food, drugs, and other products in the United States.

Got photos? Submit your photos here. ›

What they’re saying

“The Warning Letter largely seeks additional details on these measures to confirm current and future regulatory compliance; it does not make any conclusions about the quality or safety of our medicines.”

— Novo Nordisk (Novo Nordisk statement)

What’s next

Novo Nordisk said it is 'working diligently' to address the concerns raised by the FDA in the warning letter. The FDA will likely monitor the company's progress in resolving the issues identified.

The takeaway

This case underscores the importance of drug manufacturers strictly adhering to FDA reporting requirements for potential safety issues. Failure to do so can erode public trust and put patient health at risk, especially for popular medications like Ozempic and Wegovy.