TGA removes Andrographis from low-risk ingredient list, urging recalls

The Therapeutic Goods Administration announced that Andrographis paniculata will be removed from the Permissible Ingredients Determination, meaning it can no longer be marketed as a low-risk component in medicines. The decision follows 1,468 reported adverse reactions to 90 products containing the herb, ranging from anaphylaxis to a death reported in June 2024. The regulator will ask manufacturers to voluntarily recall or cancel their ARTG listings by mid-October, with compulsory recalls possible if firms do not act.

BioCeuticals, a major supplier, has stopped releasing stock and is coordinating with the TGA on voluntary withdrawal. Researchers such as Connie Katelaris of Western Sydney University praised the action, noting the high number of severe allergy cases linked to the herb. Consumers have been advised to avoid products with Andrographis until the recall process is completed.