The title of this article is unfortunate, but all too true! We have blogged about dietary supplements with undeclared drug ingredients, dangerous products like Kratom with its inherent safety issues, and a host of other unapproved prescription or OTC drug products that continue to appear in the marketplace. But this one takes the cake! The FDA is warning patients and healthcare providers “not to use counterfeit Ozempic (semaglutide) injection 1 milligram (mg) which has been found in the legitimate U.S. supply chain.”

The FDA and other federal agencies as well as Novo Nordisk (Ozempic’s innovator) are investigating the counterfeit product and working together to identify its source and how the product entered the legitimate supply chain. The FDA is also warning wholesalers, pharmacies, and healthcare practitioners to be on alert for the counterfeit product and to report any findings to the Agency. In addition, the FDA warns patients to “obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product before using for any signs of counterfeiting.” Currently, the counterfeit product can be identified through its lot number and serial number (see photo below).

counterfeit blog in-post image

The Agency indicates that, while the reports of adverse events associated with use of the counterfeit version of Ozempic are basically the same as those for the legitimate product, the needles supplied with the product are also counterfeit and the FDA, therefore, cannot ensure the sterility of either the needles or the counterfeit product itself.

The FDA’s notice also contains graphics to help identify the packaging of the counterfeit needles versus authentic Ozempic needles. The full FDA notice can be found here. This is just another example of how greed can trigger illegal actions to the detriment of patient safety.