FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain
Report a problem with a product to FDA
[12/5/2025] FDA recently seized dozens of units of counterfeit Ozempic (semaglutide) injection 1 mg that were distributed illegally outside of Novo Nordisk's authorized supply chain. The seized counterfeit products were in the legitimate U.S. drug supply chain. The counterfeit products are labeled with lot number - PAR1229 - which also is an authentic lot number.
The counterfeit products labeled with lot number PAR1229 can be identified by the location of the EXP/LOT text on the pen's label. The counterfeit product has the EXP/LOT text on the left side of the expiration date and lot number, while the authentic Ozempic pen contains the EXP/LOT text above the expiration date and lot number.
Authentic vs. counterfeit pen
Patients should not use Ozempic if the EXP/LOT text appears on the left side of the expiration date and lot number on the pen's label. Patients who received Ozempic injection 1mg with lot number PAR1229 through the Novo Nordisk Patient Assistance Program may continue using the product as it is authentic Ozempic.
Recommendations for patients, retailers, wholesalers and health care professionals
FDA advises patients, wholesalers, retail pharmacies and health care professionals to check the Ozempic products they have received and not use, distribute or sell products that contain the counterfeit information above.
The agency is aware of six adverse event reports associated with this lot. However, these adverse events are associated with authentic Ozempic and none of them appear to be associated with the counterfeit product. All six adverse events were reported by Novo Nordisk.
FDA urges retail pharmacies to only purchase authentic Ozempic through authorized distributors of Novo NordiskExternal Link Disclaimer and review the product and information to confirm the legitimacy of their shipments. Pharmacists with concerns about whether their batches are authentic should contact Novo Nordisk customer care at 1-800-727-6500 Monday through Friday from 8:30 a.m. to 6 p.m. EST.
Patients should only obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product before using for any signs of counterfeiting.
FDA's ongoing investigation
Testing and analysis of the seized products are underway to determine the drug's composition and safety risks.
FDA was notified by Novo Nordisk on Nov. 18, 2025, that counterfeit Ozempic injection 1mg was in the legitimate U.S. drug supply chain. FDA's investigation is ongoing, and the agency is working to protect the U.S. drug supply.
The agency takes reports of possible counterfeit medicines seriously and works closely with other federal agencies and the private sector to help protect the nation's drug supply. FDA is working with Novo Nordisk to identify, investigate and remove further suspected counterfeit Ozempic injectable products found in the U.S.
Visit Novo Nordisk's announcement for more information.
Report adverse events
Health care professionals and consumers should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online at MedWatch Online Voluntary Reporting Form or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
[4/14/2025] FDA was notified by Novo Nordisk on April 3, 2025, that several hundred units of counterfeit Ozempic (semaglutide) injection 1mg were in the U.S. drug supply chain. The counterfeit products were distributed outside the Novo Nordisk authorized supply chain in the U.S. FDA seized the identified counterfeit products on April 9, 2025.
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 labeled with lot number PAR0362 and serial number starting with the first eight digits 51746517 as pictured below.
FDA is aware of six adverse event reports associated with this lot, however none of them appear to be associated with the counterfeit product. All six adverse events were reported by Novo Nordisk.
FDA and Novo Nordisk are testing the seized products and do not yet have information about the identity, quality or safety of these drugs. FDA’s investigation is ongoing, and the agency is working to protect the U.S. drug supply. Visit Novo Nordisk’s announcement for more information.
Report a problem with a product to FDA.
[12/21/2023] FDA continues to investigate counterfeit Ozempic (semaglutide) injection 1 milligram (mg) in the legitimate U.S. drug supply chain and has seized thousands of units of the product. The agency advises wholesalers, retail pharmacies, health care practitioners and patients to check the product they have received and not distribute, use, or sell products labeled with lot number NAR0074 and serial number 430834149057 as pictured below. Some counterfeit products may still be available for purchase.
FDA and Novo Nordisk (manufacturer of Ozempic) are testing the seized products and do not yet have information about the drugs’ identity, quality, or safety.
Additionally, analysis found the needles from the samples are counterfeit. Accordingly, the sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use the counterfeit products. Based on analyses completed to date, other confirmed counterfeit components within the seized products are the pen label, accompanying health care professional and patient information, and carton.
FDA is aware of five adverse events from this lot, none of which are serious and are consistent with known common adverse reactions to authentic Ozempic, which are nausea, vomiting, diarrhea, abdominal pain and constipation.
FDA recommends retail pharmacies only purchase authentic Ozempic through authorized distributors of Novo Nordisk and review the photographs and information to confirm the legitimacy of their shipments. Patients should only obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product before using for any signs of counterfeiting.
FDA takes reports of possible counterfeit products seriously and works closely with other federal agencies and the private sector to help protect the nation’s drug supply. FDA’s investigation is ongoing, and the agency is working with Novo Nordisk to identify, investigate, and remove further suspected counterfeit semaglutide injectable products found in the U.S.
Health care professionals and consumers should report adverse events or side effects related to the use of this product to FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online at MedWatch Online Voluntary Reporting Form or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Entities, including online sellers, selling counterfeit and/or tampered medicines should be reported to FDA. Suspected counterfeit products may be reported to FDA by calling your local FDA consumer complaint coordinator or by reporting it directly at report suspected criminal activity.
Retailers and patients may also contact Novo Nordisk customer care at 1-800-727-6500 Monday through Friday from 8:30 a.m. to 6 p.m. ET with questions or concerns.
Visuals of authentic and counterfeit needles are shown below:
More Information:
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