FDA Alert: Counterfeit Ozempic found in U.S. Supply Chain

Summary:

  • The FDA and Novo Nordisk have issued an alert about counterfeit Ozempic (semaglutide) 1 mg injections found in the U.S. drug supply chain, labeled with lot number PAR0362 and serial numbers starting with 51746517.
  • These products were distributed outside of Novo Nordisk’s authorized channels and seized by the FDA on April 9, 2025. Their composition and safety are unknown, and they should not be used, sold, or distributed.
  • This is part of an ongoing issue, with similar counterfeit cases reported in December and June 2023 involving fake components, unsterile needles, and incorrect medications.

FDA Alert

The FDA and Novo Nordisk have issued a joint alert about counterfeit versions of Ozempic injections that have been found within the US drug supply chain. Several hundred units of counterfeit Ozempic were identified and distributed outside of Novo Nordisk’s authorized supply channels. The FDA seized the counterfeit products on April 9, 2025, and an investigation is underway. Both agencies emphasize that these products should not be used, sold, or distributed under any circumstances due to potential safety risks. 

The counterfeit products are labeled with a lot number PAR0362 and a serial number starting with the first eight digits 51746517. PAR0362 is an authentic Novo Nordisk lot number, but the 51746517 serial number is illegitimate. If your box of Ozempic has the lot number PAR0362, and a serial number beginning with the first eight digits, 51746517, Novo Nordisk is advising that these products should not be used. The composition and safety of these counterfeit products have not been confirmed, and their use could pose serious health risks. An investigation is ongoing.

This is not the first time counterfeit Ozempic has been found in the US drug supply chain. In December 2023, the FDA seized thousands of units labeled as Ozempic with the lot number NAR0074 and serial number 430834149057. The FDA found that these products contained several counterfeit components, including the pen label, carton, patient and healthcare provider inserts, and, notably, counterfeit needles, raising concerns about sterility and risk of infection. There were five adverse events reported in connection to this lot; none were serious and aligned with the side effects of authentic Ozempic. 

Earlier, in June 2023, Novo Nordisk and the FDA investigated a counterfeit Ozempic pen found at a retail pharmacy in the U.S. that reportedly contained insulin glargine. This is another medication used to treat diabetes that works completely differently than semaglutide. The patient experienced an adverse reaction that prompted a broader investigation. The counterfeit pen and carton featured visual discrepancies, like misspellings, poor-quality labels, and mismatched batch numbers. 

In February 2025, the Arkansas State Board of Pharmacy used new product verification technology from the National Association of Boards of Pharmacy called Pulse to identify a counterfeit Ozempic unit. An inspector deployed Pulse to quickly confirm that the product was not genuine, a discovery that led to the immediate suspension of the distributor's license. 

These incidents underscore that counterfeit Ozempic continues to pose a serious risk to public health. Patients and healthcare providers should remain vigilant, verify packaging and serial numbers, and report any suspicious products to the FDA or Novo Nordisk.

Product Photos

FDA, April 2025
FDA, April 2025