PLAINSBORO, N.J., December 21, 2023 – At Novo Nordisk, patient safety is a top priority, and we are committed to supporting the active fight against counterfeit Novo Nordisk products and other illegal activity in the market.
Novo Nordisk has become aware of several thousand units of Ozempic® (semaglutide) injection 1 mg determined to be outside the Novo Nordisk authorized supply chain. Product that contains lot number NAR0074 and serial number, 430834149057, as pictured below, are counterfeit and should not be used.
FDA has issued an alert on this counterfeit product, and Novo Nordisk is working with FDA to identify and investigate any further potential counterfeit semaglutide injectable products found in the U.S.
To date there have been five adverse events reported from this lot, all of which have been categorized as non-serious, and are consistent with the adverse event profile of authentic Ozempic® product. It is not clear, at this time, if these incidents included legitimate product or the counterfeit product.
FDA and Novo Nordisk are testing the seized product and do not yet have conclusive information about the drugs’ identity, quality, or safety.
Analyses and testing of the product is underway. Visual examination confirms that needles from these samples are counterfeit. Accordingly, Novo Nordisk cannot confirm their sterility, which may present an increased risk of infection for patients who use the counterfeit product. However, additional testing is needed to definitively determine product composition.
Retail pharmacies are advised to purchase authentic Ozempic® (semaglutide) injection 1 mg and other semaglutide-containing medicines through authorized distributors of Novo Nordisk. Pharmacies are encouraged to review the photographs and information provided above. If there is concern, please call Novo Nordisk customer care at 1-800-727-6500 Monday through Friday from 8:30 AM to 6:00 PM EST.
Patients are encouraged to only acquire Ozempic® (semaglutide) injection 1 mg through pharmacies and to check the product before using for any signs of counterfeiting as outlined above.
If an individual is experiencing any side effects that may be related to the use of a counterfeit product, that person should immediately discontinue use and contact their healthcare provider, and is additionally encouraged to report the event to FDA’s MedWatch Safety Information and Adverse Event Reporting Program (1-800-FDA-1088 or www.fda.gov/medwatch) as well as to Novo Nordisk, using the same customer care number (1-800-727-6500).
Websites selling counterfeit and/or tampered medicines should be reported to FDA. Suspected counterfeit products may be reported to FDA by calling your local FDA consumer complaint coordinator or by reporting it directly here Report Suspected Criminal Activity (fda.gov).
Ozempic® (semaglutide) injection 0.5 mg, 1 mg or 2 mg is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist indicated along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes with known heart disease.