FDA Warns Consumers About Counterfeit Ozempic in U.S. Drug Supply
The FDA is warning consumers, pharmacies, and health care professionals about multiple instances of counterfeit Ozempic (semaglutide) injection 1 mg being found in the legitimate U.S. drug supply chain. The counterfeit products were distributed outside Novo Nordisk’s authorized supply chain and have been seized by the agency as part of an ongoing investigation.
In the most recent alert (December 5, 2025), the FDA seized counterfeit Ozempic labeled with lot number PAR1229, which is also a legitimate lot number. The counterfeit version can be identified by the placement of the “EXP/LOT” text on the pen label—it appears to the left of the expiration date and lot number, rather than above it as on authentic Ozempic pens. Patients who received Ozempic with this lot number through Novo Nordisk’s Patient Assistance Program may continue using it, as those products are confirmed to be authentic.
Earlier cases in 2025 and 2023 involved additional counterfeit lots (including PAR0362 and NAR0074), with thousands of units seized nationwide. Testing revealed that some counterfeit products contained fake components, including non-sterile needles, posing an increased risk of infection. While the FDA has received several adverse event reports associated with these lots, none have been directly linked to the counterfeit products, and reported side effects were consistent with those of authentic Ozempic.
The FDA urges patients to obtain Ozempic only with a valid prescription from state-licensed pharmacies and to carefully inspect products before use. Pharmacies and wholesalers are advised to purchase Ozempic exclusively from Novo Nordisk–authorized distributors and to quarantine any suspected counterfeit products.
FDA and Novo Nordisk continue to test seized products to determine their composition and safety risks. The agency is working with federal partners and the manufacturer to identify, investigate, and remove counterfeit Ozempic from the U.S. market. Consumers and health care professionals are encouraged to report suspected counterfeit products or adverse events through the FDA’s MedWatch program.