| TGA Action ID |
RC-2026-RN-00785-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Swisse Beauty Skin Regeneration+
Product Code: 01-141-20602
Batch Numbers: 144520 &143217
Expiry Date: July 2028 |
| ARTG Number |
343070 |
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class II |
| Reason for the Action |
Elemental impurities testing identified an out of specification result for lead in two packed batches of Swisse Beauty Skin Regeneration+ where lead levels exceeded the maximum oral Permitted Daily Exposure (PDE) of 5 micrograms per day by 0.24 micrograms based on the recommended adult daily dose of two capsules per day.
The excess lead exposure represents approximately 3-5% of ordinary dietary lead intake. In the worst-case scenario of continuous daily use, the modelled blood lead increment is approximately 0.2 micrograms/dL at most, which is neither measurable nor clinically meaningful in any population, including pregnant women. |
| Instructions for Customers/Users |
Customers are to:
- Inspect their stock on hand and quarantine any affected stock to prevent further use or distribution.
Swisse will organise with customers to dispose of or return affected stock. |
| Action Commencement Date |
12/10/2026 |
| Responsible Entity |
|
| Contact Information |
0421 612 699, Sanjana Sanjappa - Swisse Wellness |