FDA Issues Warning About Counterfeit Ozempic
The U.S. Food and Drug Administration (FDA) and Novo Nordisk are warning people not to use counterfeit semaglutide 1.0 mg (Ozempic injection) found in the US drug supply chain.
Novo Nordisk notified the FDA on April 3, 2025 that several hundred units of the fake product had been distributed outside the company’s authorized supply chain. The FDA seized the identified products on April 9, 2025, but some may still be circulating.
Patients, wholesalers, retail pharmacies, and healthcare professionals are advised to check Ozempic boxes for the lot number PAR0362 and serial number beginning with the first eight digits, 51746517. The lot number is legitimate, but the serial number is counterfeit. Any product with serial number 51746517 should not be used, distributed, or sold, the FDA said in a statement.
Patients should only obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product for counterfeiting before using, Novo Nordisk advised.
There have been six adverse event reports associated with the lot, although these are consistent with typical gastrointestinal reactions to semaglutide, and none appear to be associated with the counterfeit product, according to the FDA.
Novo Nordisk and the FDA are working together to test the seized products for identity, quality, and safety. Thus far, they have confirmed that other product components including the needles, pen labels, packaging, and the accompanying product inserts for patients and professionals are all counterfeit. The sterility of the needles can’t be confirmed, introducing an infection risk, the FDA said.
Those in possession of a counterfeit product are encouraged to report it to Novo Nordisk customer care at 1-800-727-6500 Monday through Friday from 8:30 AM to 6:00 PM EST and to report any adverse events to the FDA here: https://www.accessdata.fda.gov/scripts/medwatch/.
Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X (formerly Twitter) @MiriamETucker and BlueSky @miriametucker.bsky.social
