Buyer beware. The Food and Drug Administration is warning people to watch out for shipments of counterfeit Ozempic that are currently flooding the market.
The FDA and Ozempic manufacturer Novo Nordisk jointly issued an alert about the fakezempic last week. Several hundred units of the counterfeits are thought to have entered the drug supply chain. It’s not clear whether these units present a unique safety risk at this point, but regardless, the FDA is telling patients, pharmacies, and doctors not to use or distribute them if identified.
According to the alert, Novo Nordisk first notified the FDA about the counterfeit drugs on April 3, which were distributed outside the company’s authorized supply chain in the U.S. The FDA says it managed to seize some of these drugs on April 9. The products can be identified by a combination of the lot number PAR0362 (an authentic lot) and a serial number starting with the first eight digits 51746517 (not authentic).
The counterfeits are specifically labeled as 1 milligram doses of Ozempic, which is approved to treat type 2 diabetes. Since the approval of Novo Nordisk’s Wegovy—a higher dose formulation of the same active ingredient (semaglutide) approved for obesity— in 2021, Ozempic has become a popular off-label medication for weight loss as well.
The FDA has received six adverse event reports connected to this specific lot of Ozempic (all submitted by Novo Nordisk), but none have involved the counterfeit products. Both the FDA and Novo Nordisk are testing the seized counterfeit products, but they don’t yet have any information on the quality, safety, or identity of the products.
This isn’t the first time that counterfeit Ozempic has reached the public. In 2023, the FDA and health agencies in other countries reported a similar counterfeit problem, with the FDA seizing thousands of units that entered the U.S. supply chain that year. In at least some cases, the faux products actually contained insulin, and several users were hospitalized with insulin overdoses as a result. The FDA also noted in 2023 that the needles used to inject these drugs were counterfeit as well, raising the risk of improper sterilization. Last year, the World Health Organization sent out its own alert after being notified of counterfeit batches being sold in Brazil, the UK, and the U.S.
Then as now, the FDA is warning people to not take any chances and to stay away from these faux products.
“The agency advises patients, wholesalers, retail pharmacies and health care professionals to check the Ozempic products they have received and not use, distribute or sell products” identified as counterfeit, the FDA said in its alert.
