TLDR
- The FDA sent Novo Nordisk a warning letter dated March 5 over failure to report side effects linked to semaglutide, the ingredient in Ozempic and Wegovy.
- Three deaths — including one suicide — were cited, with the FDA saying Novo failed to investigate or report the suicide case.
- Novo Nordisk has two weeks to inform the FDA of corrective actions it plans to take.
- The company said it does not expect the warning to impact production or investment guidance.
- NVO stock is down 27% year to date, trading around $38.32.
Novo Nordisk has been having a rough year, and this latest development isn’t helping.
Novo Nordisk got a warning letter from the US Food and Drug Administration for not reporting all suspected side effects in patients who took its blockbuster Ozempic. https://t.co/lKuoummBrc
— Bloomberg (@business) March 10, 2026
The FDA issued a warning letter to the Danish drugmaker on March 5, citing “serious violations” related to how it reported — or failed to report — potential side effects linked to semaglutide, the active ingredient in Ozempic and Wegovy.
The violations were discovered during an inspection of a Novo Nordisk facility in New Jersey last year.
Three deaths were flagged in the letter, including two deaths and one suicide. The FDA said Novo failed to investigate or report the suicide case within the required time frame.
The FDA was clear that it is not saying the medications caused these deaths. The concern is about the reporting process, not a direct causal link.
“FDA relies on the complete, accurate, and timely submission of ADEs to monitor a product’s safety profile,” the agency wrote, referring to adverse drug events.
Novo Nordisk has been given two weeks to notify the FDA of the steps it will take to prevent future violations.
The company responded publicly, saying it has been working “diligently” to address the FDA’s concerns. It confirmed it had sent the agency an initial response and seven follow-up updates.
Novo also said the cited cases “have been evaluated” and have since been “processed and reported appropriately.” The company did not deny that it had previously failed to report them.
A Pattern of Regulatory Issues
This is not the first time Novo has been in the FDA’s crosshairs recently. In December, a separate warning letter was sent to its Bloomington, Indiana facility over violations of Good Manufacturing Practice regulations.
Last month, the FDA also issued two letters criticizing Ozempic and Wegovy advertisements for “false or misleading claims” about efficacy and risk. One February 26 letter accused Novo of framing Ozempic as superior to competing drugs.
Novo acknowledged the pattern in its press release, noting simply: “We work in a highly regulated space.”
The company says it does not expect the latest warning to affect production or the financial guidance it has recently outlined to investors.
Stock Down 27% Year to Date
NVO has taken a beating in 2026. The stock was trading around $38.32, down 27% year to date, putting it well off its highs.
The slide has come from multiple directions — regulatory pressure and growing competition from Eli Lilly, maker of rival GLP-1 drug Mounjaro, have both weighed on sentiment.
Political headwinds have added to the pressure. Health Secretary RFK Jr. has publicly criticized Ozempic as overpriced, and last year blocked a Biden-era proposal that would have expanded Medicare coverage of GLP-1 drugs to around 7 million Americans.
The stock was trading at $38.32 as of Tuesday afternoon.
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