Counterfeit Ozempic is circulating in the US, prompting a warning from the Food and Drug Administration (FDA). The agency, along with Ozempic manufacturer Novo Nordisk, issued a joint alert urging consumers, pharmacies, and healthcare professionals to be vigilant. This isn’t the first instance of fake Ozempic appearing in the market, raising serious concerns about patient safety.
The counterfeit Ozempic is labeled as 1mg doses, the same dosage approved for treating type 2 diabetes. Ozempic’s active ingredient, semaglutide, is also found in Wegovy, a higher-dose formulation approved for obesity. Since Wegovy’s approval in 2021, Ozempic has gained popularity as an off-label weight-loss medication. This increased demand may be contributing to the rise in counterfeit versions.
The FDA was first alerted to the counterfeit drugs by Novo Nordisk on April 3, 2024. These fraudulent products were distributed outside Novo Nordisk’s authorized US supply chain. The FDA successfully seized some of these counterfeits on April 9. The affected products can be identified by the lot number PAR0362 (a legitimate lot number) and a serial number beginning with the first eight digits 51746517 (not a legitimate serial number).
Several hundred units of the counterfeit Ozempic are estimated to have entered the US drug supply. While the specific safety risks associated with these counterfeits remain unclear, the FDA strongly advises against their use or distribution. The agency and Novo Nordisk are currently testing the seized products to determine their quality, safety, and composition.
This incident follows previous reports of counterfeit Ozempic in 2023. The FDA, along with international health agencies, seized thousands of counterfeit units that year. Some of these fake products contained insulin, leading to hospitalizations due to insulin overdoses. Furthermore, the FDA reported that the needles used with the counterfeit drugs were also fake, posing a risk of improper sterilization. The World Health Organization issued a global alert after counterfeit batches were discovered in Brazil, the UK, and the US.
The FDA emphasizes the importance of avoiding these counterfeit products. Patients, wholesalers, retail pharmacies, and healthcare professionals should carefully examine any Ozempic they receive and refrain from using, distributing, or selling products identified as counterfeit. Report any suspected counterfeit Ozempic to the FDA immediately.
