In 2023, Ozempic was discovered at a pharmacy in Niesky, Germany. The Food and Drug Administration has issued a warning to patients and doctors to verify the authenticity of their Ozempic prescriptions following the seizure of several hundred units of fake versions of the diabetes medication in the U.S.
Novo Nordisk, the manufacturer of Ozempic and the weight loss drug Wegovy, informed the FDA on April 3rd about counterfeit 1-milligram injections being distributed outside of their authorized supply chain in the U.S. The agency seized the counterfeit products, labeled with lot number PAR0362 and serial numbers starting with the first eight digits 51746517, on April 9th. The counterfeit products likely entered the market through unofficial channels such as unauthorized distributors or resellers.
Although six adverse event reports linked to the lot have been reported, none appear to be associated with the counterfeit product. The FDA and Novo Nordisk are conducting tests to determine the safety of the fake products.
The counterfeit Ozempic highlights the high demand for the diabetes medication, which is sometimes used for weight loss purposes. In December 2023, the FDA seized thousands of fake Ozempic units and warned that some may still be available for purchase.
It’s important to note that the fake products are distinct from compounded versions of the drug, which have also gained popularity in the U.S. The FDA permits compounded versions of drugs that are essentially copies of commercially available drugs under specific circumstances like shortages. In February, the shortage of Ozempic and Wegovy in the U.S. was resolved, leading to the discontinuation of the sale of less expensive compounded versions of the medications.