| TGA Action ID |
RC-2026-RN-00775-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Phytologic PhytoBio Immune Enhance & Phytologic Activated Immune Enhance
Phytologic Activated Immune Enhance 10 capsules
Batch Number & Expiry Date:42395 (SEP 2027)
Phytologic Activated Immune Enhance 30 capsules
Batch Number & Expiry Date: 42396 (SEP 2027)
Phytologic PhytoBio Immune Enhance 10 capsules
Batch Number & Expiry Date: 44918 (OCT 2028)
Phytologic PhytoBio Immune Enhance 30 capsules
Batch Number & Expiry Date: 44919 (OCT 2028) |
| ARTG Number |
451826 |
| 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. |
| Instructions for Customers/Users |
Distributors/Retailers
• Inspect stock immediately and quarantine all stock of Phytologic PhytoBio Immune Enhance & Phytologic Activated Immune Enhance on hand to prevent further use or distribution.
• Please return all affected stock to Phytologic
• 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.
• If someone is suspected of having anaphylaxis, call for emergency medical help immediately by dialling ‘000’. |
| Action Commencement Date |
9/10/2026 |
| Responsible Entity |
|
| Contact Information |
+61 2 9700 8850 - Phytologic Customer Services or
customerservice@phytologic.com.au |