FDA alerts public to counterfeit Ozempic lot NAR0074 in US supply chain

Counterfeit Ozempic (semaglutide) injection 1 milligram reached the legitimate U.S. drug supply chain, the FDA said on Dec. 21, 2023, and the agency identified what it had seized by lot number NAR0074 and serial number 430834149057 ^[1].

The FDA said thousands of units were confiscated in the investigation, and that some of the fake product could still be bought. Wholesalers, retail pharmacies, health care practitioners and patients were told to inspect what they have and to avoid using, selling or distributing anything carrying those identifying numbers ^[1]. The alert includes pictures of the counterfeit carton, label and needles so a shipment can be checked against them ^[1].

Along with the pen label, the patient and health care professional information sheets and the outer carton were confirmed fakes, according to the agency. The needles in the samples were counterfeit as well, which means their sterility cannot be confirmed — a finding the FDA said raises the risk of infection for anyone who uses them ^[1].

The FDA and Novo Nordisk, which makes Ozempic, are still testing the seized units. The agency said it does not yet have information about the identity, quality or safety of those drugs, leaving open whether they contain semaglutide and in what amount ^[1].

Five adverse events have been reported in connection with the lot. The FDA described none of them as serious, and said they match the reactions already known to occur with authentic Ozempic: nausea, vomiting, diarrhea, abdominal pain and constipation ^[1].

For pharmacies, the agency recommended buying only through Novo Nordisk's authorized distributors and reviewing shipments to confirm they are genuine. For patients, it said Ozempic should be obtained with a valid prescription from a state-licensed pharmacy, with the product checked for signs of counterfeiting before use ^[1]. Questions can go to Novo Nordisk customer care at 1-800-727-6500, Monday through Friday, 8:30 a.m. to 6 p.m. ET ^[1]. Side effects and suspected fakes can be reported to the FDA through MedWatch or a local FDA consumer complaint coordinator ^[1].

Why it matters for patients

Fake Ozempic had already been a concern on unregulated websites. This alert marked a different problem: the affected units were sitting in the same supply channel that stocks ordinary retail pharmacies, so a prescription filled at a licensed counter was not by itself a guarantee against receiving one of the flagged pens ^[1].

The needles are a distinct worry from the drug. Even if the liquid turns out to be harmless, a needle that was not made or sterilized under regulated conditions can introduce infection, and the FDA said it could not verify that these were sterile ^[1].

What the pens actually contain has not been disclosed. The FDA said the seized products' identity, quality and safety are still unknown ^[1]. The agency also did not say precisely how many units were taken beyond "thousands," how far they spread, or which pharmacies or states received them ^[1].

The five adverse events do not establish that the fakes harmed anyone. They were reported as not serious and as resembling the side effects of genuine Ozempic ^[1].

What happens next

The investigation is ongoing, with the FDA and Novo Nordisk working to find and remove additional suspected counterfeit semaglutide injectables from the U.S. market ^[1]. No timeline for the testing results was given ^[1]. No recall of authentic Ozempic was announced, and the agency did not name a pharmacy, wholesaler or distributor as the source of the fake units ^[1].

The FDA's alert page has since been updated with additional counterfeit Ozempic notices — one posted April 14, 2025 involving lot PAR0362, and one posted Dec. 5, 2025 involving lot PAR1229, which the agency noted is also an authentic lot number ^[1].