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Medical Product Alert No. 2/2024: Counterfeit OZEMPIC (semaglutide)

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Warning Summary

This WHO Medical Product Alert relates to three counterfeit batches of OZEMPIC (semaglutide). This counterfeit product was discovered in Brazil (October 2023), the United Kingdom of Great Britain and Northern Ireland (October 2023) and the United States of America (December 2023) and supplied in the regulated supply chain.

OZEMPIC (semaglutide) belongs to a group of medicines called glucagon-like peptide-1 (GLP-1) inhibitors and is indicated for the treatment of hyperglycemia associated with type 2 diabetes mellitus in adults, adolescents and children over 12 years of age.

The original manufacturer of OZEMPIC has confirmed that the three products mentioned in this warning are counterfeits: The products misrepresent their identity and origin as they are not manufactured by Novo Nordisk:

  • Lot number LP6F832 is not recognized.
  • The combination of batch number NAR0074 with serial number 430834149057 does not correspond to the genuine manufacturing documents.
  • Lot number MP5E511 is genuine, but the product is counterfeit.

WHO has previously cautioned that national regulators need to exercise caution with some of these batches, as well as with similar GLP-1 agonist products in general.

Full details of the affected products can be found in the appendix to this alert.

Risks

The use of counterfeit OZEMPIC may result in ineffective treatment of patients due to incorrect dosage, contamination with harmful substances or use of unknown or substituted ingredients. Due to the subcutaneous injection administration, it may pose other serious health risks that may be life-threatening.

Advice to healthcare professionals, regulatory authorities and the public

Healthcare professionals should report all incidents of adverse reactions, lack of efficacy and suspected falsification to the national regulatory authorities or the national pharmacovigilance centre.

National regulatory/health authorities are encouraged to contact their marketing authorisation holders for advice on detecting counterfeits, to strengthen monitoring of informal sales, including online sales, and to promptly notify WHO when they detect such counterfeit products.

If you have one of the affected products, WHO recommends that you do not use it. If you or someone you know has used or may have used the affected product, or has experienced an adverse reaction or unexpected side effect after using it, you should seek medical attention immediately.

All medical products must be sourced from authorized/licensed suppliers. If you have any information about the manufacture or supply of these counterfeit products, please contact WHO at [email protected].

Ways to identify counterfeit products

  1. Check the batch number and serial number: WHO recommends against distributing, using or selling products marked with the batch numbers listed in the Annex.
  2. Examine the pen: Counterfeit Ozempic pens may have a scale protruding from the pen when setting the dose.
  3. Evaluate the quality of the label: The label may be of poor quality and may not stick well to the pen.
  4. Watch for spelling mistakes: There may be spelling mistakes on the front of the box.

WHO Global Monitoring and Surveillance System

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