Urgent recall issued for 13 immune supplements containing andrographis after fatal reaction

Why This Matters

• Immune system supplements are widely used, and this recall highlights serious safety risks for consumers.
• Many people may have these products at home without knowing the potential for severe allergic reactions.
• The fatal incident underscores the importance of acting on adverse reports and tightening regulations.

Background

Andrographis is an herbal ingredient used in some immune support supplements. Since 2019, products containing it have been required to carry a warning label about the risk of allergic reactions. The TGA continued to receive anaphylaxis reports after that requirement, and a fatal reaction led to andrographis being removed from the Permissible Ingredients Determination in September 2024. The subsequent recall covers 13 products that contain the ingredient.

Key Perspectives

[TGA]: The regulator acted after receiving a high number of anaphylaxis reports and a fatal incident, prioritising consumer safety by removing the ingredient from the permissible list and issuing a recall. [Manufacturers and Sponsors]: They are responsible for recalling the affected products from shelves and ensuring consumers are informed about returning goods. [Consumers]: Those who have purchased these supplements should check their supplies and stop using them immediately, returning them to the place of purchase or contacting the supplier.

What to Watch

• Whether additional products containing andrographis are identified and added to the recall.
• The outcome of any TGA investigation into manufacturers and their compliance with labelling requirements.
• Possible changes to ingredient regulations for herbal supplements in response to ongoing safety concerns.