The U.S. Food and Drug Administration (FDA) and the manufacturer of Ozempic, Novo Nordisk, are issuing a warning about counterfeit semaglutide 1.0 milligram injections found in the U.S. drug supply chain. This counterfeit product has been discovered in the market, prompting both the FDA and Novo Nordisk to advise against its use.
Novo Nordisk informed the FDA on April 3 that several hundred units of counterfeit Ozempic had been distributed outside the company’s authorized supply chain. The counterfeit product was identified, and the FDA seized these units on April 9. However, there is still a possibility that some counterfeit units may still be circulating in the market, and the FDA has urged patients, pharmacies, wholesalers, and healthcare providers to be vigilant.
The counterfeit semaglutide has been linked to a specific lot number, PAR0362, and serial numbers starting with 51746517. While the lot number is authentic, the serial number associated with these products is counterfeit. The FDA has confirmed that any Ozempic product containing the serial number 51746517 should not be used, distributed, or sold. Patients and healthcare providers are advised to thoroughly inspect the product’s labeling and packaging before use to ensure that they are receiving a legitimate product.
Ozempic is widely used for the treatment of type 2 diabetes and for weight loss, and the growing demand for such treatments has unfortunately led to the infiltration of counterfeit versions into the market. These fake products pose significant health risks to individuals relying on them for managing their diabetes or weight loss goals.
While there have been reports of adverse events associated with the counterfeit batch, these reports indicate symptoms commonly associated with the use of semaglutide itself, such as digestive issues. None of the adverse events appear to be directly linked to the counterfeit nature of the product at this time. Nonetheless, the FDA and Novo Nordisk are conducting tests on the seized products to assess their identity, quality, and safety.
One of the major concerns surrounding counterfeit Ozempic is the risk it poses in terms of sterility. The packaging, needles, pen labels, and product inserts for patients and healthcare professionals have all been confirmed to be counterfeit. The needles associated with the fake products cannot be guaranteed to be sterile, which increases the risk of infection. Injections using non-sterile needles can introduce harmful bacteria or pathogens, leading to potentially serious infections.
Patients should ensure they obtain their prescription medications, including Ozempic, from licensed pharmacies and should only purchase from authorized sources. Counterfeit medications are often distributed through unverified or unauthorized channels, which increases the likelihood of encountering these dangerous products. Consumers should also take the necessary steps to check for signs of counterfeiting, such as inconsistencies in the product packaging, labeling, or any unusual characteristics.
If individuals suspect that they are in possession of counterfeit Ozempic, they are strongly encouraged to contact Novo Nordisk’s customer service at 800-727-6500. The company operates this helpline Monday through Friday from 8:30 a.m. to 6:00 p.m. EST. Patients and healthcare professionals should also report any adverse events related to counterfeit or questionable products to the FDA to help ensure the safety of all users.
The issue of counterfeit drugs is an ongoing challenge in the pharmaceutical industry, particularly with high-demand medications like Ozempic. Both the FDA and Novo Nordisk are committed to resolving this issue by working together to remove counterfeit drugs from the market and protect public health.
