Counterfeit Ozempic 1 mg pens seized from US supply chain, FDA says
Counterfeit Ozempic 1 mg pens were pulled from the U.S. supply chain in April 2025, and the FDA still does not know what the fake units contain.
The FDA seized several hundred counterfeit Ozempic (semaglutide) 1 mg injection pens on April 9, 2025, four days after Novo Nordisk alerted the agency that the units had reached the U.S. drug supply chain [1][2].
Novo Nordisk's notification was dated April 3, 2025 [1][2]. The FDA said the fake pens had moved through channels outside the manufacturer's authorized distribution network [1][2]. The agency's warning to the public followed in a MedWatch bulletin dated April 14, 2025 [1][2].
Two markings set the suspect product apart: lot number PAR0362, and serial numbers beginning with the eight digits 51746517 [1][2]. The FDA asks patients, wholesalers, retail pharmacies and health care professionals to examine what they have on hand and to avoid using, distributing or selling pens that carry those identifiers [1][2].
The agency has logged six adverse event reports tied to the lot. None appear to involve the counterfeit product, and all six came from Novo Nordisk [1][2].
What the seized pens contain is still unknown. Testing by the FDA and Novo Nordisk is underway, and the agency said it does not yet have information about the identity, quality or safety of the drugs [1][2]. The investigation remains open [1][2].
This has happened before
Counterfeit Ozempic 1 mg turned up in the legitimate supply chain in late 2023 as well. In a December 21, 2023 update, the FDA said it had seized thousands of units bearing lot number NAR0074 and serial number 430834149057, and cautioned that some fakes might still be for sale [1].
Laboratory review at the time found the needles in those samples were counterfeit too, so their sterility could not be confirmed — a finding the agency said raised the risk of infection [1]. The FDA recorded five adverse events from that lot, none serious, with symptoms matching the known common reactions to authentic Ozempic: nausea, vomiting, diarrhea, abdominal pain and constipation [1].
Why it matters for patients
Ozempic is approved for adults with type 2 diabetes, as an addition to diet and exercise for blood sugar control and to lower the risk of major cardiovascular events in patients who also have established cardiovascular disease [2].
A counterfeit pen is not the medicine the FDA reviewed. In the current case, no one has said what the seized units contain or whether they are safe [1][2]. In the 2023 case, the counterfeit needles alone were a concern because sterility could not be verified [1].
Patients have no way to test a pen at home, but the lot and serial numbers the agency published are printed on the pen and carton, so they can be matched against the alert [1][2]. The FDA advises filling Ozempic prescriptions only through state-licensed pharmacies and inspecting the product before use; it also advises pharmacies to buy only from Novo Nordisk's authorized distributors [1][2]. Online sellers and others offering counterfeit or tampered medicines can be reported to the FDA [2].
Novo Nordisk customer care takes questions at 1-800-727-6500, weekdays from 8:30 a.m. to 6 p.m. Eastern time [1][2]. Side effects and adverse events can be reported to the FDA's MedWatch program online or by calling 1-800-332-1088 [2].
What happens next
The FDA has not released results from the testing of the April 2025 units and has given no date for when it will [1][2]. The agency says it is continuing to work with Novo Nordisk to identify, investigate and remove any other suspected counterfeit Ozempic injectables in the U.S. [1][2].
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