FDA warning letter: Novo Nordisk Inc.
What the FDA told Novo Nordisk Inc. in September 2025 about semaglutide and liraglutide — and whether it has been resolved.
“Food and Drug Administration (FDA) has reviewed the promotional communication, a direct-to-consumer video (video), titled “An Oprah Special: Shame, Blame, and the Weight Loss Revolution,” regarding WEGOVY (semaglutide) injection, for subcutaneous use (Wegovy), OZEMPIC ® (semaglutide) injection, for subcutaneous use (Ozempic), and VICTOZA® (liraglutide) injec …”
What an FDA warning letter is
It is a letter. The FDA writes to a company to say which of its practices the agency believes break the law, and asks it to fix them. That is the whole mechanism: a written notice, published so anyone can read it.
It is the FDA’s position, not a court’s finding. The company can reply, and can disagree. The agency states in these letters that failing to address the problems may lead to further action such as seizure or an injunction — which tells you the letter itself is not yet either of those things.
A warning letter does not recall a product, suspend a licence or close a business. It does not mean that medicine already dispensed was unsafe. When the FDA is satisfied the problems are fixed, it publishes a closeout letter.
What it does tell you is that a regulator looked at this company and wanted something changed. The useful question is what — and the quoted passage above answers it more precisely than any summary can.
What the letter says
| Field | What the letter states | Source |
|---|---|---|
| Recipient | Novo Nordisk Inc. | FDA warning letter |
| Issued | Sep 9, 2025 | FDA warning letter |
| Issuing office | Center for Drug Evaluation and Research (CDER) | FDA warning letter |
| FDA reference | MARCS-CMS 716495 | FDA warning letter |
| Location | Plainsboro, NJ, United States | FDA warning letter |
| Subject | False & Misleading Claims/Misbranded | FDA warning letter |
| What it concerns | What the website claimed | Read from the subject line |
| Medication named | Semaglutide and Liraglutide | Letter text |
| Status | Open — no closeout letter published | FDA warning letter list |
The FDA sent 8 other letters that day
These letters go out in waves rather than one at a time, so the rest of the wave is the context this one sits in.
- FDA warning lettersPublished compliance actions, updated weekly
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NADAC figures are pharmacy acquisition costs, not retail prices and not what you will pay. This content is educational and is not medical advice.