Counterfeit semaglutide spreads through illegal online sales

Novo Nordisk and the U.S. Food and Drug Administration have warned that counterfeit Ozempic (semaglutide) pens were found in the "legitimate" U.S. drug supply chain, not just through illegal online sellers. The FDA told distributors, pharmacies, health care workers and patients not to use products carrying Lot number NAR0074 or serial number 430834149057, a 1 mg injectable dose. Thousands of units from that lot were seized, but the FDA said some may still be circulating.^[2]

Five people who used products from the flagged lot reported side effects, but the agency said those effects — nausea, diarrhea and vomiting — matched known side effects of real Ozempic, not something new or unusual.^[2] Novo Nordisk said it is not yet certain whether every unit from the lot is counterfeit. In a public statement, the company said it "cannot guarantee the quality or safety of the counterfeit Ozempic product," adding that a visual check found the needles and cartons appeared fake, though the actual contents of the pens have not been conclusively determined.^[2]

The FDA and Novo Nordisk specifically flagged the needles as a concern, warning that counterfeit needles could raise the risk of infection for anyone who injects with them.^[2] This U.S. discovery followed similar problems abroad. In October, health officials in the United Kingdom and elsewhere in Europe warned about falsified Ozempic pens turning up in their markets.^[2]

The counterfeit problem has grown alongside a supply squeeze. Demand for GLP-1 drugs like semaglutide and tirzepatide has outpaced what manufacturers can produce, and unauthorized compounders and sellers have moved to fill the gap. Novo Nordisk sued two compounding pharmacies in Florida in November over unauthorized versions of its drugs.^[2] Eli Lilly, which makes tirzepatide products, sued 10 medical spas, wellness centers and compounding pharmacies in September for selling products falsely marketed as Mounjaro.^[2] Neither Ozempic nor Mounjaro were in short supply everywhere, but demand has been intense: Ozempic and Wegovy combined brought in $4.7 billion in third-quarter sales, or 57% of Novo Nordisk's total revenue that quarter, while Mounjaro sales hit $1.4 billion in the same period.^[2]

Why it matters for patients

For people using semaglutide, the core risk is not knowing what is actually inside a pen bought outside a normal pharmacy channel. Novo Nordisk said it could not confirm the true contents of the fake pens even after finding that the outer packaging and needles looked counterfeit.^[2] That uncertainty matters because a counterfeit product could contain the wrong dose, no active drug at all, or contaminants, and a fake needle raises the separate risk of infection at the injection site.^[2]

The fact that counterfeits reached the "legitimate" U.S. supply chain, not just shady websites, means patients cannot assume that where they got a pen automatically guarantees it is real.^[2] The FDA's warning applies to a specific lot and serial number, but the agency has said thousands of units were already seized while some may remain in use, so people who received Ozempic around the time of this alert may want to check whether their product matches the flagged lot information.^[2]

What happens next

The FDA said it was continuing to investigate how counterfeit units entered the supply chain and asked anyone who suspects they have a counterfeit product to report it.^[2] Novo Nordisk's lawsuits against Florida compounders and Eli Lilly's suits against medical spas and pharmacies selling fake Mounjaro were both filed as the companies sought to crack down on unauthorized versions of their drugs, though the outcomes of those cases were not detailed in available reporting.^[2] One source describing a broader Novo Nordisk warning about a surge in counterfeit Ozempic and Wegovy sales could not be accessed for this article, so some details of that alert are not yet known.^[1]