Counterfeit Ozempic pens detected

These counterfeit Ozempic pens may pose a serious health risk and should not be used. There are clear differences from the original product to look out for.

The TGA has received one report of a life-threatening event in Australia after a person used a counterfeit pen labelled as Ozempic that contained insulin. This pen was bought overseas.

Insulin is a different type of medicine that should only be used when directed and prescribed by a health professional. Unintended use of insulin can cause dangerously low life-threatening blood sugar levels.

About the counterfeit Ozempic pens

The pens are currently undergoing laboratory testing. However, as the safety, quality and efficacy of these products are unknown, they may pose a serious health risk and should not be used.

Both the product detected by ABF and the one associated with the adverse event show several differences when compared to legitimate Ozempic pens.

Counterfeit products may have spelling errors, instruction leaflets not in English, unsealed packaging, changes in medicine size, shape, or appearance.

The two products subject to the TGA alert both appear to be relabelled insulin pens. The end cap is blue (not grey), the dosage barrel is in a different place, the sticker is not stuck properly to the pen and the packaging is poor quality.

The batch numbers labelled on the pens (NPSG234 and JS7A925) have been confirmed as not genuine batch numbers by Novo Nordisk, the manufacturer of Ozempic.

This highlights the need to purchase your medicines from legitimate sources.

The products detected by ABF were purchased online from an overseas website. They were not bought from an Australian pharmacy.

Although consumers who hold a valid prescription can lawfully import prescription-only medicines such as Ozempic (semaglutide) under the personal importation scheme, counterfeit products − whether bought knowingly or unknowingly − cannot be imported under any circumstances, even if a prescription is provided.

A reminder 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 the TGA 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 buying them from an Australian pharmacy.

From 1 October 2024, Australian pharmacies will not be allowed to compound glucagon-like peptide-1 receptor agonists (GLP-1 RAs) like Ozempic (semaglutide). Visit the TGA news alert for more information.

Information for consumers

• Call 000 or get other emergency medical assistance if you or someone else has symptoms of severe low blood sugar levels (hypoglycaemia) after using a product labelled as Ozempic. This might include weakness, trembling, shaking, confusion and unconsciousness.
• If you have any other concerns about using a product labelled as Ozempic, consult your health care professional.
• 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 the TGA may request it for testing
• If you are considering buying medicines or medical devices online from overseas, watch this short video on the risks associated with doing this.

Report counterfeit medicines and medical devices

If you are worried about counterfeit medicines or medical devices- external site, 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 the TGA may request it for testing.