Notice of CRITICAL RECALL
TGA reference: RC-2026-RN-00818-1
Vitaceuticals Immunity Boost Forte (30s & 60s)
What happened?
In agreement with the Therapeutic Goods Administration (TGA), Vitaceuticals (Pharmacy Healthcare Pty Ltd) is conducting a recall of all batches of Immunity Boost Forte that are still within expiry.
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.
Further information on this decision is available on the TGA website.
The product subject to this recall is:
| Product | Batch / lot number | Expiry | AUST L |
|---|---|---|---|
| Immunity Boost Forte (30s & 60s) | B:3121702 B4060901 |
05/2027 08/2027 |
443110 |
What are the risks?
- Anaphylaxis is the most severe type of allergic reaction and is a medical emergency.
- It requires immediate treatment with adrenaline (epinephrine). Delayed treatment can be life threatening.
- Andrographis-related anaphylaxis reactions are unpredictable and can happen the first time someone takes it, or after taking it previously without any issue.
What should consumers do?
If you have this product, do not use it. You can return the product to the place of purchase to arrange the return of the product for a refund.
If someone is suspected of having anaphylaxis, call for emergency medical help immediately by dialling ‘000’.
Further information?
If you have any questions regarding this recall, please contact us on 1300 362 406 or email support@vitaceuticals.com.au.