WASHINGTON, April 15: The US Food and Drug Administration (FDA) on Monday urged patients and healthcare providers to verify the authenticity of their Ozempic prescriptions after the agency confiscated several hundred counterfeit units of the popular diabetes drug in the U.S.

According to a news release from the FDA, pharmaceutical company Novo Nordisk — which manufactures Ozempic and the weight loss drug Wegovy — alerted the agency on April 3 that 1-milligram doses of counterfeit Ozempic injections were being distributed outside of the company’s authorized supply chain. This indicates the products likely entered the market through unauthorized distributors or resellers.

On April 9, the FDA seized the counterfeit injections, which are labeled with lot number PAR0362 and serial numbers beginning with 51746517.

The agency also noted that it has received six reports of adverse events linked to this lot. However, none of those incidents appear to be directly associated with the counterfeit product. Both the FDA and Novo Nordisk are currently testing the seized products to assess their contents and determine potential safety concerns. Since even genuine Ozempic can cause side effects such as gastrointestinal issues, it remains unclear if the reported adverse events stemmed from typical use or the fake products.

The discovery highlights the increasing demand for Ozempic, which, while developed to treat type 2 diabetes, has surged in popularity for its off-label use in weight loss. Similar glucagon-like peptide-1 (GLP-1) drugs have also seen a rise in demand.

This isn’t the first counterfeit seizure involving the drug. In December 2023, the FDA announced it had seized thousands of fake Ozempic units and warned that some may still be circulating in the market.

These fake injections are distinct from compounded versions of semaglutide, which are permitted under FDA rules in certain circumstances — particularly during shortages. However, in February, the FDA declared that shortages of Ozempic and Wegovy had been resolved in the U.S., effectively curbing the legal production and sale of compounded alternatives.

The FDA continues to advise consumers and healthcare professionals to obtain medications through legitimate, authorized channels and to report any suspected counterfeit products.