FDA seizes counterfeit Ozempic from the US supply chain

The US Food and Drug Administration seized several hundred units of counterfeit Ozempic (semaglutide) injection 1 mg on April 9, 2025, after Novo Nordisk notified the agency on April 3 that the fake products were circulating in the US drug supply chain ^[1][2]. The counterfeit products were distributed outside Novo Nordisk's authorized US supply chain ^[1][2].

The FDA published a MedWatch alert about the seizure on April 14, 2025 ^[2].

What to look for on the label

The agency advised patients, wholesalers, retail pharmacies and health care professionals to check the Ozempic products they have received and not to use, distribute or sell products labeled with lot number PAR0362 and a serial number starting with the first eight digits 51746517 ^[1][2]. The FDA published a photo of the counterfeit label alongside its alert ^[1][2].

The FDA said it is aware of six adverse event reports associated with this lot, but none of them appear to be associated with the counterfeit product ^[1][2]. All six were reported by Novo Nordisk ^[1][2].

At the time of the announcement, the FDA and Novo Nordisk were testing the seized products and did not yet have information about the identity, quality or safety of the drugs ^[1][2]. In other words, what is actually inside these pens is not yet known. The FDA said its investigation is ongoing and that the agency is working to protect the US drug supply ^[1][2].

This is not the first time

In December 2023, the FDA said it had seized thousands of units of counterfeit Ozempic 1 mg from the legitimate US supply chain, labeled with lot number NAR0074 and serial number 430834149057 ^[1]. In that case, testing found the needles in the samples were counterfeit, so their sterility could not be confirmed, which the agency said presents an increased risk of infection for anyone who used the products ^[1]. Other confirmed counterfeit components in that 2023 seizure included the pen label, the health care professional and patient information, and the carton ^[1]. The FDA said it was aware of five adverse events from that lot, none serious, and consistent with known common reactions to authentic Ozempic: nausea, vomiting, diarrhea, abdominal pain and constipation ^[1].

Why it matters for patients

Counterfeit pens that reach retail pharmacies can look convincing. In the April 2025 case, the fakes carried a lot number and serial number range that the FDA asked people to check against their own boxes and pens ^[1][2]. That puts some of the burden of detection on pharmacies and, ultimately, on the person holding the pen.

The practical risks are twofold. First, the contents are unverified — the FDA said it did not yet have information on identity, quality or safety of the seized April products ^[1][2]. That means the dose could be wrong, absent, or something other than semaglutide. Second, as the 2023 investigation showed, counterfeit needles may not be sterile, raising infection risk ^[1].

The FDA's stated recommendations are that retail pharmacies only purchase authentic Ozempic through Novo Nordisk's authorized distributors and review the photographs and information to confirm shipments are legitimate, and that patients only obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product before using for signs of counterfeiting ^[1][2].

The agency also said entities, including online sellers, that sell counterfeit or tampered medicines should be reported to the FDA, and that retailers and patients can contact Novo Nordisk customer care at 1-800-727-6500 with questions or concerns ^[1][2]. Novo Nordisk's line operates Monday through Friday, 8:30 a.m. to 6 p.m. ET ^[1].

Health care professionals, patients and consumers are encouraged to report adverse events or side effects to the FDA's MedWatch program, either online or by calling 1-800-332-1088 to request a reporting form, which can be faxed to 1-800-FDA-0178 ^[2].

What happens next

• April 3, 2025: Novo Nordisk notified the FDA that counterfeit Ozempic 1 mg was in the US supply chain ^[1][2].
• April 9, 2025: The FDA seized the identified counterfeit products ^[1][2].
• April 14, 2025: The FDA issued its MedWatch alert naming lot PAR0362 and serial numbers beginning 51746517 ^[2].

The FDA has not published a date for when testing results on the seized April 2025 products will be released ^[1][2].