TGA's October 20 update further expands the Andrographis recall list as Australia continues product-level action over unpredictable anaphylaxis risk.

Australia's Therapeutic Goods Administration has again expanded its consolidated list of Andrographis-containing medicines being recalled because of the risk of severe allergic reactions.

The TGA market-action page was originally published October 1 and is now last updated October 20, 2026. Its current table includes additional medicines associated with Wagner Professional, Swisse, Nature's Care, Biosource, Pharmacy Health PLUS, MEDIX and COLES, alongside products from Fusion Health, BioCeuticals, Phytologic, AYUNA, Nourex and other sponsors previously added during October. [1]

The underlying safety concern has not changed: Andrographis-related anaphylaxis can be severe, unpredictable and potentially life-threatening.

What continues to change is the product-level implementation of Australia's regulatory decision.

October 20 Update: TGA's Recall List Expands Again

When MedicalToxic first reported this story on October 5, the public recall list was much narrower.

The TGA subsequently expanded the consolidated table several times during October. Its October 20 version includes additional products and sponsors that were not present in MedicalToxic's October 16 update. [1]

The current consolidated product list is:

The product names, ARTG identifiers, sponsors and consolidated recall scope above follow the current TGA table. [1]

Operational batch note: The consolidated TGA page summarizes many entries as covering all unexpired batches, while individual Database of Recalls, Product Alerts and Product Corrections records may enumerate specific batch numbers currently within expiry. Pharmacies, distributors and other inventory holders should use the individual linked TGA recall record for operational stock reconciliation.

For example, the individual Nature's Care record lists specific batches for Immune Forte 1-A-Day and Immune Defence, even though the consolidated page summarizes the products as covering all unexpired batches.

AYUNA ARTG Discrepancy Remains

A source discrepancy identified in MedicalToxic's previous update remains present.

TGA's October 20 consolidated table displays AUST L 284724 for AYUNA AMA CARE. However, the linked individual official recall record identifies:

AYUNA AMA CARE 60 / 100 VEG capsules — ARTG 282724 (cancelled)

and specifies batch 2038, expiry 06/2028. [2]

Because the product-specific DRAC record is the more granular regulatory record for that recall, MedicalToxic uses ARTG 282724 above and preserves this discrepancy transparently rather than silently reproducing the conflicting consolidated number.

The October 20 Date Is Not the Recall Date for Every Product

The date at the top of TGA's consolidated page is the date that page was last updated.

It should not be interpreted as meaning that every product listed there began its recall on October 20.

Individual sponsor recalls commenced at different times during October. For example, the MEDIX/COLES action commenced October 14, the Nature's Care, Biosource and Pharmacy Health PLUS actions commenced October 15, and the Wagner Professional and Swisse recalls commenced October 16.

The October 20 update therefore represents an expanded consolidated regulatory snapshot, not a single mass-recall commencement date.

What Consumers Should Do

TGA advises consumers to check the current product table.

Unless an individual recall states otherwise, consumers who have one of the affected medicines should:

• not use the product;

• return it to the place of purchase or contact the relevant sponsor or supplier;

• speak with a health professional if concerned about a medicine they have been taking; and

• call 000 immediately if anaphylaxis is suspected.

[1]

TGA describes anaphylaxis as a medical emergency requiring immediate treatment with adrenaline, or epinephrine. This News does not expand that regulator statement into a separate anaphylaxis treatment protocol.

Why Australia Escalated Its Andrographis Action

The current recalls are the product-level implementation of a broader regulatory decision.

Since 2019, listed medicines containing Andrographis paniculata have been required to carry a warning about allergic reactions, including severe reactions such as anaphylaxis.

Despite those measures, TGA continued receiving reports of Andrographis-associated anaphylaxis and concluded that the risk could not be adequately managed within Australia's lower-risk listed-medicines framework. [3]

From September 17, 2026, Andrographis was removed from the ingredients allowed in new listed medicines intended for supply in Australia.

That ingredient-level decision did not automatically recall every existing Andrographis product on the Australian market.

Instead, sponsors have progressively implemented product-specific actions, including ARTG cancellation, cessation of supply and consumer-level recalls.

The expanding October consolidated list reflects that sponsor-by-sponsor implementation.

Regulatory Timeline

June 2024: TGA received the fatal Andrographis-associated anaphylaxis case that continues to be referenced in its current regulatory materials. It is a historical case, not a new October 2026 death.

April 2026: TGA published its updated safety review and supplementary report, incorporating adverse-event data through December 31, 2025. [4]

September 17, 2026: Andrographis was removed from the permissible-ingredients framework for new listed medicines.

October 1, 2026: TGA published its consolidated Andrographis recall page. [1]

During October: individual sponsors progressively implemented consumer-level product recalls.

October 20, 2026: TGA again updated the consolidated recall page, adding further affected medicines and sponsors. [1]

These stages should remain separate: ingredient-level regulation, product-specific market action and historical safety evidence are related but are not the same regulatory event.

The Fatal Case Is Historical, Not a New October Death

TGA continues to reference a fatal case involving Andrographis, but the timing is important.

The fatal case was reported in June 2024.

It forms part of the evidence supporting Australia's regulatory action. It should not be described as a death caused by the October 2026 product recalls or as a newly reported October fatality.

The current development is the continuing expansion of product-level recalls.

The Anaphylaxis Signal Remains Substantial

TGA's updated safety review and supplementary report state that the agency had received 287 reports of anaphylaxis linked to Andrographis-containing medicines from 2005 through December 31, 2025, including the fatal case reported in 2024. [4]

Those reports are pharmacovigilance data.

They should not be treated as an incidence rate. The number of exposed consumers is not known from those reports, spontaneous reporting is incomplete, and an adverse-event report does not by itself establish causality in every individual case.

TGA nevertheless concluded after reviewing Australian and international adverse-event reports, medicine formulations, published evidence, toxicological information and expert advice that severe allergic-reaction risk could not be adequately mitigated in the listed-medicines framework.

Previous Tolerance Does Not Guarantee Safety

One of the key toxicologic and clinical features of the Andrographis signal is its unpredictability.

TGA states that reactions can occur on first exposure or after previous use without a reaction.

Its detailed review found that most evaluable cases occurred either in people using the suspected medicine for the first time or in people who had previously used it without a reaction. Most evaluable cases also had rapid symptom onset, often within 30 minutes.

Previous uneventful use therefore does not guarantee that a later exposure will be tolerated.

Is Every Andrographis Medicine in Australia Recalled?

No.

The TGA's ingredient-level decision and the current product recalls should not be collapsed into one claim.

Andrographis is no longer permitted as an ingredient in new listed medicines under the affected framework, but existing medicines required separate regulatory and sponsor action.

The October 20 consolidated page identifies the medicines for which current recall action has been published. [1]

It would therefore be inaccurate to state that every Andrographis-containing medicine in Australia was recalled simultaneously.

Because TGA has repeatedly updated the list during October, consumers and healthcare professionals should consult the current regulator page rather than relying on an older screenshot or fixed product count.

Why This Matters for Medical Toxicology

Andrographis is a herbal ingredient used in multiple complementary medicines, including products marketed for immune and respiratory support.

The current regulatory concern is not conventional dose-dependent overdose toxicity.

It is severe and unpredictable hypersensitivity, including anaphylaxis.

That distinction matters because there is no simple toxic-dose threshold that separates affected from unaffected consumers, and previous tolerance does not reliably predict safety on subsequent exposure.

The episode is also a broader reminder that “natural,” herbal or complementary-medicine status does not eliminate the potential for severe adverse reactions.

What Is Genuinely New?

The underlying Andrographis anaphylaxis signal is not new.

The September ingredient-level regulatory decision is also not new.

The genuine October 20 development is the continued expansion of product-level implementation.

TGA's consolidated table now includes additional products associated with Wagner Professional, Swisse, Nature's Care, Biosource, Pharmacy Health PLUS, MEDIX and COLES, alongside the medicines already present in earlier October snapshots. [1]

The regulatory story has therefore progressed from:

persistent safety signal → ingredient-level restriction → initial sponsor recalls → expanding product-by-product market action.

That is why the existing MedicalToxic News page remains the correct living owner rather than creating another Andrographis News URL.

Limitations and Remaining Unknowns

The 287 adverse-event reports cannot establish population incidence.

TGA's recall table also does not mean that every listed medicine generated the same number or severity of reactions.

No product-specific anaphylaxis incidence rate is provided for each recalled medicine.

The current consolidated list may also continue to change as additional sponsor actions are completed.

For that reason, MedicalToxic should not freeze a total number of affected product names into the headline or evergreen metadata.

The regulator's live list should remain the operational source for the current scope.

Conclusion

Australia's Andrographis safety action is continuing to expand at the product level.

As reflected in TGA's consolidated page updated October 20, 2026, additional medicines and sponsors have now joined the recalls already reported earlier in October. [1]

The regulatory rationale remains unchanged: TGA concluded that severe, unpredictable Andrographis-associated allergic reactions, including anaphylaxis, could not be adequately managed within Australia's low-risk listed-medicines framework. [3]

The historical fatal case remains the June 2024 case, not a new October death, and the pharmacovigilance data should not be converted into an incidence rate.

For consumers and healthcare professionals, the practical message remains precise:

check the current TGA recall list, stop using affected products, follow the relevant sponsor's return instructions, and treat suspected anaphylaxis as a medical emergency.

References

1. Therapeutic Goods Administration. (2026, October 1; updated October 20).
   Andrographis recalls: Concerns over allergy risk

2. Therapeutic Goods Administration. (2026).
   Database of Recalls, Product Alerts and Product Corrections — AYUNA AMA CARE 60 / 100 VEG capsules, RC-2026-RN-00791-1

3. Therapeutic Goods Administration. (2026, September 18).
   High-moderate risk changes to permissible ingredients - Andrographis paniculata 2026

4. Therapeutic Goods Administration. (2026, updated April 8).
   Andrographis paniculata (Andrographis) and anaphylaxis - updated safety review and supplementary report