Andrographis removed from listed medicines framework because of allergy risk

We have continued to receive reports of anaphylaxis linked to medicines containing Andrographis. This includes a fatal case reported in June 2024.

Following the publication of an updated safety review and supplementary report in April 2026, and consideration of submissions received through the High-moderate risk changes to Andrographis 2026, a decision has been made to remove Andrographis from the Therapeutic Goods (Permissible Ingredients) Determination.

From 17 September 2026, new medicines containing Andrographis will no longer be eligible to be listed in the Australian Register of Therapeutic Goods (ARTG) for supply in Australia.

Medicines that are already listed on the ARTG will not be removed immediately. This means people may still see and buy some Andrographis products.

We will ask sponsors to voluntarily cancel affected products or recall them where appropriate. If sponsors do not act quickly, we may consider stronger regulatory action, including compulsory recalls or ARTG cancellations.

• Check whether your medicine contains Andrographis.
• Consider whether you should keep using it.
• Talk to a health professional if you are unsure what to do.
• Call 000 immediately if you or someone else may be having anaphylaxis.

Signs of anaphylaxis can include difficulty breathing, swelling of the tongue or throat, wheezing, dizziness, collapse, stomach pain or vomiting.

• Advise patients based on their individual circumstances.
• Be aware that reactions may happen on first use or after previous use without problems.
• Tell patients that reactions often happen within 30 minutes.
• Report suspected problems with medicines or vaccines to the TGA.

• Sponsors of listed medicines containing Andrographis are strongly encouraged to take voluntary action.
• This may include:
  • Voluntarily cancelling the medicine's ARTG entry.
  • Working with manufacturers to cease manufacture and release of stock for supply.
  • Undertaking a consumer-level recall.
• Sponsors wishing to recall products should follow the TGA recall process and seek TGA agreement before contacting customers.
• If sponsors do not take timely voluntary action, the TGA will start taking regulatory action from mid-October 2026.
• Sponsors of export-only listed medicines that contain Andrographis should review their products and consider implications of the TGA’s safety findings for continued supply.

For more information, please refer to High-moderate risk changes to Andrographis 2026.