FDA Issues Urgent Warning About Counterfeit Ozempic in U.S. Supply Chain

FDA Issues Urgent Warning

The United States Food and Drug Administration (FDA) recently published a notice of concern over the vulnerability of the nation’s drug supply chain to counterfeit Ozempic. The agency acted promptly after receiving a report on April 3 2025,from Novo Nordisk, the drug maker of Ozempic, that illegal distributors had brought into circulation counterfeit copies of the best-selling drug for diabetes and weight loss.

Originally meant to manage type 2 diabetes, Ozempic is increasingly being used as a weight loss medication and even prescribed off-label quite often. As a result of the recent increased demand, fake products have started emerging and are now being discovered in the American market.

The FDA established that several hundred units of fake Ozempic, i.e., the 1-milligram injections with lot number PAR0362, were seized. The serial numbers of these items, which start with the number 51746517, were used to identify them. Moreover, the agency revealed that although six adverse events had been reported in connection with the counterfeit lot, none of them were found to have any direct connection with the counterfeit drug.

The agency and Novo Nordisk are carrying out tests on the imitation products in a bid to ascertain the safety of the counterfeit products.

As Ozempic has been in the limelight for its possible effects of making people lose weight, the warning comes as the alarm over the rising demand for the drug rises. It is unclear, however, if the side effects reported were normal or linked to the fake drugs, as the FDA reiterated that genuine Ozempic injections do carry side effects, which include abdominal pain.

Unauthorized resellers or distributors were probably the channel via which the counterfeit lots of Ozempic were being sold. This is a dangerous trend since patients might unknowingly buy these counterfeit versions while searching for cheaper options, jeopardizing their health.

The compounded form of the drug, also available for sale in the United States, differs from the fake. Under some circumstances, like when commercially available drugs are scarce, using compounds is fine. The FDA had previously mentioned that by February 2025, the shortage of Wegovy, another drug from Novo Nordisk, and Ozempic would have ended. The demand for compounded preparations, usually at a lesser cost, was eliminated by this invention.

The FDA encourages patients and healthcare professionals to exercise caution and confirm that the prescriptions they fill for Ozempic are valid as part of the ongoing investigation. To protect themselves against fake goods, the organization advises patients to only buy their prescription drugs from reliable vendors, such as authorized pharmacies.

The FDA’s announcement comes at a time of unprecedented demand for weight-loss drugs. As drugs like Ozempic have gained in popularity, illicit activity has filled the void created by the tremendous growth in demand.

The FDA is continuing to watch the illicit activity to protect patients against harm caused by fake drugs. The warning from the FDA is certainly an important reminder of the dangers related to fake drugs and about the need to verify the authenticity of drugs in a healthcare environment that is getting more complicated.