1 of 2 | Novo Nordisk Ozempic drug retails for $$997.58 for four injections to be used weekly. Counterfeit ones in 1 mg strength have been reported in the United States. Photo by Ida Marie Odgaard/EPA-EFE
The U.S. Food and Drug Administration on Monday warned consumers and pharmacies that fake versions of Ozempic, a drug to treat Type 2 diabetes, have been found in the United States.
Novo Nordisk, the Danish-headquartered manufacturer, informed the FDA on April 3 that counterfeit 1-milligram injections of semaglutide were being distributed outside its authorized supply chain.
The drug is sold in 0.5 mg, 1 mg and 2 mg doses, and are injected weekly.
The fake products likely entered the market through unauthorized distributors or resellers, the agency and company said.
Counterfeit products — labeled with lot number PAR0362 and serial numbers starting with the first eight digits 51746517 — were seized by the FDA on Wednesday.
Lot number PAR0362 is authentic, the company said. Only when the lot number is coupled with the eight digits 51746517, it is counterfeit.
The FDA and Novo Nordisk are testing the fake products to identify whether they’re safe.
The agency said six adverse event reports linked to the lot were linked to the lot but none appear to be associated with the counterfeit product. The drug normally can have side effects.
Patients are asked to obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product for any signs of counterfeiting.
People in possession of the fake product are urged to call Novo Nordisk customer care at 800-727-6500 Monday through Friday from 8:30 a.m. to 6 p.m. EDT and report it to the FDA’s criminal activity division’s website.
Side effects can be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program (800-FDA-1088 or www.fda.gov/medwatch) as well as to Novo Nordisk, at 800-727-6500.
Ozempic is a glucagon-like peptide 1, or GLP-1, receptor agonist to improve glycemic control in adults with Type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events.
Ozempic has been used off-label by people seeking to lose weight. The retail price is $998 for four injections to be used weekly.
Wegovy is the company’s weight loss drug, which also is an injectable.
In 2024, Novo Nordisk’s Ozempic generated nearly $17 billion in sales and Wegovy brought in around $8 billion.
Eli Lilly’s Type 2 diabetes drug is Mounjaro and the weight-loss version is Zepbound.
