| TGA Action ID |
RC-2026-RN-00811-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Immunitone Plus
Product Code: IMP090-AU
Batch Numbers: All batches within expiry (40242, 40900, 42137, 42574, 43680, 45550)
Expiry Dates: 11/2026 to 03/2029 |
| ARTG Number |
383995 |
| Action Type |
Recall |
| Action Level |
Consumer |
| Hazard Classification |
Class I |
| Reason for the Action |
Since 2019, listed medicines containing Andrographis paniculata (Andrographis) for supply in Australia have been required to carry a label warning about the risk of allergic reactions including severe reactions such as anaphylaxis.
However, despite these warnings, the TGA has continued to receive a sustained high number of reports of anaphylaxis associated with Andrographis-containing listed medicines, which are considered low-risk medicines.
Andrographis has now been removed from the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2026. This means the ingredient is no longer available for use in new listed (low risk) medicines for supply in Australia.
Since 2018, seven adverse events have been reported in Australia for this product (including under previous ARTG entries), two of them serious, including one life-threatening allergic reaction. No deaths and no overseas adverse events have been reported. |
| Instructions for Customers/Users |
Distributors/retailers/practitioners:
· Inspect your stock immediately and quarantine all stock of Immunitone Plus (AUST L 383995) on hand to prevent further use or distribution.
· Complete the attached Customer Response Form immediately even if you do not have any affected stock, and return it by email to recalls@designsforhealth.com.au or electronically via this link so Designs for Health can reconcile this recall.
· Following receipt of returned stock, Designs for Health will arrange a refund or replacement for the returned stock.
· Retailers are recommended to place the ‘Public Notice’ attached to this letter in their storefront to alert consumers about the recall.
Consumers:
· Consumers are advised that if they have the above product, to not use it.
· Consumers can return the product to the place of purchase to arrange the return of product for a refund.
· If someone is suspected of having anaphylaxis, call for emergency medical help immediately by dialling ‘000’. |
| Action Commencement Date |
12/10/2026 |
| Responsible Entity |
|
| Contact Information |
02 9136 6266 or recalls@designsforhealth.com.au - Designs for Health Customer Experience |