Counterfeit Ozempic injection pens detected

Consumers and health professionals should be aware that further examples of counterfeit Ozempic-labelled products have been stopped at the Australian border. These injection pens may pose a serious risk to your health and should not be used.

Though these products appear to be genuine Ozempic injections, the batch number on these injection pens - MPSD916 - has been confirmed as not a genuine batch number by Novo Nordisk, the manufacturer of Ozempic.

Consumers should be aware that counterfeit products have not been assessed by us for quality, safety or efficacy as required under Australian legislation.

The products subject to this alert exhibited typographic inconsistencies in packaging compared to legitimate Ozempic products, including differences in spacing and bolding of the text. This is a new issue identified, distinct from the previous alert issued in September 2024 regarding counterfeit injection pens labelled as Ozempic that contained insulin.

Consumers should be warned that manufacturers of counterfeit goods are producing products that, to the untrained eye, may appear legitimate, highlighting the need to purchase your medicines from legitimate sources.

We remind consumers that products purchased over the internet:

• may be fake
• may contain the wrong or undisclosed and potentially harmful ingredients
• may not meet the same standards of quality, safety and efficacy as those approved by us for supply in Australia.

For your safety, always buy medicines from reputable sources and consult your healthcare provider or local registered pharmacy if you have any concerns.

We advise extreme caution when buying medicines from unknown overseas websites and recommend obtaining them from an Australian pharmacy.

Counterfeit products cannot be imported under the Personal Importation Scheme. Knowingly importing, supplying and/or giving away counterfeit therapeutic goods is illegal and poses a significant public health and safety risk.

Information for consumers

• Stop using counterfeit Ozempic pens including any marked with Batch number MPSD916 and take any remaining product to your local pharmacy for safe disposal.
• If you have any concerns arising from your use of this product, consult your health care practitioner.
• If you suspect you have had a side effect (also known as an adverse event) to this or a similar medicine, report it to the TGA.
  • If possible, keep the medicine, as we may request it for testing.
• If you are considering purchasing medicines or medical devices online from overseas, watch this short video on the risks associated with this.

Action we are taking

The TGA continues to check batch numbers of any products that may be subject to counterfeiting.

We are working with the Australian Border Force (ABF) to help stop future shipments of counterfeit and substandard Ozempic from entering Australia.

We will notify ABF to seize and destroy any of these products intercepted at the border.

While there are reported shortages of products such as Ozempic, we are working to provide consumers with safe alternatives, such as approving the importation of legitimate overseas-registered semaglutide products for temporary supply. Details about these overseas-registered products are available on the section 19A approvals database on the TGA website.

Report counterfeit medicines and medical devices

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA.

If you have a medicine you suspect may be counterfeit, please do not dispose of it as we may request it for testing.