TGA moves to recall Andrographis cold and flu supplements

A supplement you have probably seen on the shelf at every pharmacy in Australia is being recalled. Not because it failed to work. Because it killed someone, and the regulator has finally decided the risk is too unpredictable to leave on the market.

Andrographis paniculata — known commercially as “King of Bitters” and found across dozens of cold and flu and immune-support products — has been removed from the TGA’s list of permitted low-risk complementary medicine ingredients. The regulator received 1,468 adverse reaction reports across 90 different registered medicines containing the herb. One death was reported in June 2024. The reactions include anaphylaxis, nerve disorders, immune system effects, and urticaria. The TGA stated that delaying implementation “would likely pose an imminent or serious risk of injury to consumers.”

Manufacturers have until mid-October to voluntarily recall affected products or cancel their ARTG listings. After that deadline, compulsory recalls apply. Retailers have been asked to remove products from shelves. The practical reality is that stock already in patients’ homes will not be automatically returned — and most people taking these products do not know this has happened.

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How did we get here

Andrographis has a long history in Ayurvedic and traditional Chinese medicine, where it has been used for respiratory infections, fever, and immune support for centuries. Its transition into Australian pharmacy shelves happened largely on the basis of that traditional use record, not on clinical trial evidence at the scale required for a standard therapeutic good.

The complementary medicine regulatory pathway in Australia — ARTG listing for low-risk products, rather than registration — allows manufacturers to self-assess ingredient safety against a permitted ingredient list. Andrographis met that bar. What changed is the accumulation of adverse reaction data: 1,468 reports is not a negligible signal in the context of complementary medicines, and the nature of the reactions — anaphylaxis is not mild urticaria — elevated the clinical stakes considerably.

The TGA’s assessment, frankly stated, is that the risk is not predictable. Anaphylaxis associated with Andrographis can occur on first exposure or after repeated use without a previous reaction. That unpredictability is the core problem. An ingredient with that profile cannot be managed with a warning label — it needs to be off the shelf.

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Both sides of this story

Most people who have taken Andrographis-containing supplements have taken them without incident. The 1,468 adverse reports represent a fraction of the Australian consumer population that has used these products. The traditional-use record, spanning cultures and millennia, is not nothing. For many patients, the response to this news will be frustration: “I’ve used this for years and never had a problem.”

That frustration is understandable. And it does not change the regulatory calculus. A severe allergic reaction that is unpredictable — that cannot be reliably anticipated by allergy history or previous uneventful use — is a different category of risk than most therapeutic goods on pharmacy shelves. You cannot screen patients out of risk. You cannot counsel around it. The only available intervention is removal.

The harder structural question this raises is about the broader complementary medicine regulatory framework. Ninety different products carried this ingredient — many of them prominent, heavily marketed brands. Those products were listed on the ARTG on the basis of self-assessed safety against a standard that has now changed. The 1,468 reports presumably accumulated over time without triggering an earlier intervention. The regulatory system caught this, but not quickly.

That is not a specific criticism of the TGA’s handling of this case — regulatory processes for post-market surveillance have genuine resourcing and signal-detection challenges. It is an honest acknowledgement that the complementary medicine framework relies heavily on manufacturer compliance and post-market surveillance in a way that mainstream pharmaceutical registration does not.

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What this means in general practice this week

Ask about what your patients are taking. The complementary medicine conversation often does not happen because patients do not think to mention supplements and clinicians do not always have time to ask. A patient presenting with urticaria, facial oedema, or a first allergic reaction should be asked directly about recent supplement use — including cold and flu products — particularly if they have no obvious other trigger.

Advise current users to stop immediately. The TGA’s guidance is clear: given the unpredictable and potentially fatal risk of anaphylaxis, patients should not continue using products containing Andrographis paniculata. This applies regardless of whether they have previously had a reaction.

Recognise anaphylaxis early. Sudden-onset throat tightening, bronchospasm, angioedema, or cardiovascular instability following any ingestion — including a supplement taken routinely for years — is an anaphylaxis until proven otherwise. If your practice keeps any complementary medicines in a display or waiting room, check the label for Andrographis paniculata and remove them if present.

Be alert to the mid-October lag. The voluntary recall deadline is mid-October. Between now and then, products may still be on shelves and in patients’ homes. The gap between the announcement and the physical absence of products from the market is where the highest short-term risk sits.

The TGA’s advice is not hedged: “reconsider using products containing the herb given the unpredictable and potentially fatal risk of anaphylaxis associated with its use.” When regulators use that language, it means now.

Verdict: yes — advise any patient currently using Andrographis-containing supplements to stop, and ask about recent supplement use in any unexplained allergic presentation.

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Sources cited

1. TGA flags recall of cold and flu supplements containing Andrographis — ABC Health, 22 September 2026
2. Therapeutic Goods Administration — safety and regulation of complementary medicines