Imported Unregistered Methylene Blue Products
Summary Unregistered methylene blue products are being imported and sold in Australia without proper regulatory approval. These oral products contain methylthioninium chloride and have not been evaluated for safety and effectiveness by Australian health authorities. Consumers across Australia may have access to these unapproved products.
- Reason
- We are issuing a safety advisory about the increasing importation and use of unregistered oral methylene blue (methylthioninium chloride) products in Australia.
- Classification
- Class II
- Category
- drug recall
- Country
- Australia
- Agency
- Therapeutic Goods Administration
- Recall date
- 2025-09-25
- Status
- Ongoing
- Distribution
- Australia-wide
Official recall notice from Therapeutic Goods Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/cf08f49a-3470-4eef-b615-8ada0b3c29a2