TGA removes Andrographis paniculata from the low-risk medicine ingredient list
Australia’s TGA [Therapeutic Goods Administration] has removed Andrographis paniculata from the ingredients permitted in new low-risk listed medicines. The herb is used in some herbal cold and flu remedies, often combined with other ingredients such as Echinacea. The change took effect on 17 September 2026.
The regulator concluded that the risk of severe allergic reactions, including anaphylaxis, could not be adequately managed under this pathway. Recalls of individual products have since begun.
What changed?
- Andrographis was removed from the Permissible Ingredients Determination, the list governing ingredients for low-risk listed medicines.
- From 17 September 2026, new medicines containing Andrographis are no longer eligible for the listed-medicine pathway.
- The ingredient-level decision did not automatically recall every existing product. Recalls and cancellations require action for individual medicines.
For patients
Check the ingredients of herbal cold and flu products for Andrographis, then check whether your medicine appears on the TGA’s current recall list. Check the product and batch details, not just the brand name.
Unless the recall notice says otherwise, the TGA advises not using the listed recalled goods and returning them to the place of purchase or contacting the supplier. For other Andrographis products, reconsider whether you need them and speak with a health professional if unsure.
Call 000 immediately if anaphylaxis is suspected. This is a severe allergic reaction. Signs can include difficulty breathing, swelling of the tongue or throat, wheezing, dizziness or collapse.
For health professionals
Review relevant herbal medicine use and advise patients according to their circumstances. The TGA notes that reactions can occur on first use or after previous use without problems, often within 30 minutes.
Check current product recall instructions and report suspected adverse reactions to the TGA.
What happens next?
The TGA first published its product recall page on 1 October 2026 and updated it on 16 October 2026. It lists affected medicines and their recall instructions.
Check that page for the latest product-specific information. The ingredient-list decision and each product’s recall status are separate matters.
Disclaimer: This article is for general educational information only and is not medical advice. It does not diagnose, treat, or replace care from a qualified health professional. Always speak with a qualified health professional about personal health questions, medicines, pregnancy, medical conditions, or before changing treatment.