| TGA Action ID |
RC-2026-RN-00743-1 |
| Type of Product |
Medicine |
| Product Name/Description |
BioCeuticals ArmaForce 30, 60 & 120 tablets and BioCeuticals Clinical ImmuneForce 60 tablets
Multiple lot numbers (All lots not expired as of 08/10/2026) |
| ARTG Number |
299066, 340712 |
| 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.
Following the TGA’s determination, BioCeuticals immediately ceased supplying stock of the two affected products. |
| Instructions for Customers/Users |
Wholesalers, distributors, pharmacies, retailers:
• Inspect their stock immediately and quarantine affected stock on hand to prevent further use.
• Return the completed Customer Acknowledgement and Stock Declaration Form within five business days, even if they do not have any affected stock.
• Notify any downstream commercial customers to whom they have supplied the affected stock and instruct them to immediate cease supply and follow the recall instructions.
• After submitting the Acknowledgement and Stock Declaration Form, prepare stock for return in accordance with the instructions from BioCeuticals.
Consumers:
• Consumers are advised that if they have the above products, do not use them.
• Consumers can return the products to the place of purchase, or contact BioCeuticals to arrange a return and refund.
• If someone is suspected of having anaphylaxis, call for emergency medical help immediately by dialling ‘000’. |
| Action Commencement Date |
8/10/2026 |
| Responsible Entity |
|
| Contact Information |
1300 650 455 (Ext 4) or product.recall@bioceuticals.com.au - BioCeuticals Customer Care |