Fake Ozempic warning issued by FDA as ‘thousands of units’ seized

The US Food and Drug Administration said counterfeit popular drug Ozempic may still be in the drug supply chain and warned wholesalers, retail pharmacies, healthcare workers and patients to be wary of the products.

The FDA said Americans should check the products and if they see them labeled with lot number NAR0074 and serial number 430834149057 they should stop their distribution or use. The agency said it was continuing to investigate the issue and was able to seize thousands of counterfeit units but there could be more in the drug supply chain.

“Some counterfeit products may still be purchased,” the FDA said in a statement last week.

Newsweek The FDA was contacted by email for comment on Monday.

This photo taken on February 23, 2023, in Paris, shows the anti-diabetic drug “Ozempic” (semaglutide) produced by the Danish pharmaceutical company “Novo Nordisk”. The US Food and Drug Administration has warned consumers that there are counterfeit drugs in the US drug supply chain. (Photo by JOEL SAGET/AFP via Getty Images)

Ozempic, and other similar drugs, have gained significant popularity among people who use them for weight loss. The FDA has not yet sanctioned the use of the drug for anti-obesity treatment and it only got approval in 2017 for the treatment of diabetes. But another drug with semaglutide like Ozempic, Wegovy, has received approval to treat obesity. Both products are manufactured by the Danish company Novo Nordisk.

The FDA said it was working with Novo Nordisk to test the seized counterfeit drugs but has yet to draw conclusions about the nature of the drugs and their safety.

The agency said, however, that it is aware of five adverse effects of the drugs.

“None of these were serious and consistent with the known common adverse reactions to genuine Ozempic, which are nausea, vomiting, diarrhea, abdominal pain and constipation,” the FDA said in its statement.

Counterfeit products have needles that are also not authentic and can pose a risk of infection, the agency warns.

“Based on studies completed to date, other confirmed counterfeit components within the seized products are the pen label, along with healthcare professional and patient information, and cardboard,” said of the FDA.

The drug regulator implored pharmacies to buy Ozempic directly from approved Novo Nordisk distributors and to take all precautions to ensure the products they receive are genuine.

“Patients should only obtain Ozempic with a valid prescription through state-licensed pharmacies and inspect the product before use for any signs of counterfeiting,” the FDA said.

The agency also encouraged Americans to report any negative side effects from the drugs to the regulator.

“Entities, including online sellers, selling counterfeit and/or adulterated drugs must be reported to the FDA,” they said.

Ozempic and Wegovy became very popular with celebrities and the general consumer which greatly boosted Novo Nordisk’s business. In November, the company reported that its operating income improved by about a third and that sales at its North American operations jumped nearly 50 percent in September of 2023.

“We are very pleased with the sales growth in the first nine months of 2023, which shows that more people than ever are benefiting from our innovative diabetes and obesity treatments,” said Lars Fruergaard Jørgensen, president and CEO , the company said in a statement.