FDA MedWatch - FDA Warns Consumers Not to Use Counterfeit Ozempic (semaglutide) Found in U.S. Drug Supply Chain

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TOPIC: FDA Warns Consumers Not to Use Counterfeit Ozempic (semaglutide) Found in U.S. Drug Supply Chain

AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy

ISSUE: FDA was notified by Novo Nordisk on April 3, 2025, that several hundred units of counterfeit Ozempic (semaglutide) injection 1mg were in the U.S. drug supply chain. The counterfeit products were distributed outside the Novo Nordisk authorized supply chain in the U.S. FDA seized the identified counterfeit products on April 9, 2025.

FDA is aware of six adverse event reports associated with this lot, however none of them appear to be associated with the counterfeit product. All six adverse events were reported by Novo Nordisk.

FDA and Novo Nordisk are testing the seized products and do not yet have information about the identity, quality or safety of these drugs. FDA’s investigation is ongoing, and the agency is working to protect the U.S. drug supply. Visit Novo Nordisk’s announcement for more information.

For more information about this alert, click on the red button "Read Alert" below.

BACKGROUND: Ozempic is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.

RECOMMENDATIONS: 

• The agency advises patients, wholesalers, retail pharmacies and health care professionals to check the Ozempic products they have received and not use, distribute or sell products labeled with lot number PAR0362 and serial number starting with the first eight digits 51746517 as pictured above.

• FDA recommends retail pharmacies only purchase authentic Ozempic through authorized distributors of Novo Nordisk and review the photographs and information to confirm the legitimacy of their shipments.

• Patients should only obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product before using for any signs of counterfeiting.

• Entities, including online sellers, selling counterfeit and/or tampered medicines should be reported to FDA.

• Retailers and patients may also contact Novo Nordisk customer care at 1-800-727-6500 with questions or concerns.

Health care professionals, patients and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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