The FDA is currently investigating counterfeit Ozempic (semaglutide) injections (1 milligram) discovered within the legitimate U.S. drug supply chain. Thousands of these counterfeit units have been seized.
The FDA strongly advises wholesalers, retail pharmacies, healthcare practitioners, and patients to thoroughly inspect any products they have received. Specifically, they should avoid distributing, using, or selling products labeled with lot number NAR0074 and serial number 430834149057, as displayed in the image below. It’s important to note that some counterfeit Ozempic products may still be in circulation.
At this stage, the FDA and Novo Nordisk, the manufacturer of Ozempic, are conducting tests on the seized products. As of now, there is no information available regarding the identity, quality, or safety of these drugs.
Furthermore, analysis has revealed that the needles found in the counterfeit Ozempic samples are also fake. Consequently, the sterility of these needles cannot be verified, posing an increased risk of infection for individuals using counterfeit products. Among the confirmed counterfeit components within the seized products are the pen label, accompanying healthcare professional and patient information, and carton.
It’s worth mentioning that the FDA has knowledge of five adverse events associated with this specific lot, all of which are non-serious and consistent with known common side effects of authentic Ozempic, including nausea, vomiting, diarrhea, abdominal pain, and constipation.
FDA’s Vigilance in Combating Counterfeit Ozempic and Other Counterfeit Drugs
To mitigate risks, the FDA strongly recommends that retail pharmacies exclusively source authentic Ozempic through authorized Novo Nordisk distributors. These pharmacies should also carefully review photographs and product information to confirm the legitimacy of their shipments. Patients are urged to acquire Ozempic only through state-licensed pharmacies with valid prescriptions, and they should thoroughly inspect the product for any signs of counterfeiting before use.
The FDA treats reports of potential counterfeit products with utmost seriousness and collaborates closely with other federal agencies and the private sector to safeguard the nation’s drug supply. The FDA’s investigation is ongoing, and it is actively cooperating with Novo Nordisk to identify, investigate, and remove any suspected counterfeit semaglutide injectable products in the United States.
Entities, including online sellers, dealing in counterfeit and/or tampered medicines should promptly report such activities to the FDA. Suspected counterfeit products can be reported to the FDA by contacting your local FDA consumer complaint coordinator or by directly reporting suspected criminal activity.
Resource: FDA, December 12, 2023
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