The U.S. Food and Drug Administration (FDA) is warning consumers, patients, health care professionals, and pharmacies after counterfeit Ozempic (semaglutide) injection 1mg products were discovered in the U.S. drug supply chain.
According to the agency, Novo Nordisk, the manufacturer of Ozempic, alerted the FDA on April 3 that several hundred units of counterfeit products had been distributed outside of the company’s authorized supply channels. The FDA seized the identified counterfeit products on April 9 and has launched an investigation to assess the scope of the issue.
Although Novo Nordisk reported six adverse events related to the affected lot, none of the incidents appear to be linked to the counterfeit products. The FDA and Novo Nordisk are currently testing the seized items to determine their identity, quality, and safety. The investigation is ongoing.
Ozempic is a glucagon-like peptide 1 (GLP-1) receptor agonist used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes. It is also prescribed to reduce the risk of major cardiovascular events, such as heart attacks and strokes, in adults with type 2 diabetes and established cardiovascular disease.
The FDA has issued specific guidance to help protect the public:
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Patients, wholesalers, retail pharmacies, and healthcare professionals are urged to check Ozempic products for the lot number PAR0362 and serial numbers beginning with 51746517. Products matching these identifiers should not be used, distributed, or sold.
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Retail pharmacies are advised to purchase Ozempic only through authorized Novo Nordisk distributors and to carefully review shipments for authenticity.
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Patients should ensure they obtain Ozempic through state-licensed pharmacies with a valid prescription and should inspect products for signs of counterfeiting before use.
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Any suspected counterfeit or tampered medications should be reported to the FDA’s MedWatch system.
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Retailers and consumers with questions or concerns are encouraged to contact Novo Nordisk customer care at 1-800-727-6500.
For more detailed information, the FDA directs the public to consult Novo Nordisk’s official announcement.
