Amid the soaring demand for GLP-1 drugs used to treat diabetes and support weight loss, the U.S. Food and Drug Administration (FDA) has issued an urgent warning for consumers using Ozempic. The agency is urging users to carefully inspect their medication labels after discovering that hundreds of counterfeit Ozempic injections have entered circulation outside of the authorized U.S. supply chain.
The FDA alert follows confirmation from Novo Nordisk, the manufacturer of Ozempic and the weight loss drug Wegovy, that counterfeit 1-milligram Ozempic pens had infiltrated the U.S. market. In response, the FDA seized the identified fake products on April 9, 2025.
"The agency advises wholesalers, retail pharmacies, health care practitioners and patients to check the product they have received and not distribute, use, or sell products labeled with lot number NAR0074 and serial number 430834149057 as pictured below. Some counterfeit products may still be available for purchase," the FDA said in a news release, which included images of the counterfeit labels for reference.
In an update issued Monday, the agency further warned to be on alert for additional suspicious packaging, specifically "lots labeled PAR0362 and serial numbers starting with the first eight digits 51746517."
Six adverse events linked to the affected lot have been already reported, though none appear to be directly caused by the counterfeit product itself. All six incidents were reported by Novo Nordisk, the drug's manufacturer, as part of their ongoing monitoring efforts.
The FDA highlighted its dedication to combating counterfeit medications, stating that it "takes reports of possible counterfeit products seriously." The agency is working closely with Novo Nordisk to "identify, investigate, and remove further suspected counterfeit semaglutide injectable products found in the U.S." as part of an ongoing investigation.
Meanwhile, healthcare professionals and consumers are asked to report any side effects or adverse reactions linked to Ozempic through its MedWatch Safety Information and Adverse Event Reporting Program. Reports can be submitted online or by faxing a completed form to 1-800-FDA-0178. Additionally, anyone who suspects counterfeit or tampered medicines, especially online sellers, should contact their local FDA consumer complaint coordinator or report the activity directly through the FDA's criminal activity portal.
Originally published on Medical Daily
