OFFICIAL-SOURCE RECALL · AUSTRALIA
OPTIRAY 350 Ioversol 74% w/v 74.1g/100mL Injection Vial Recall: Classification Class III Reason for the
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CHECK THE ITEM YOU OWN
Is your product affected?
- Brand
- See official notice
- Product
- OPTIRAY 350 Ioversol 74% w/v 74.1g/100mL Injection Vial
- Manufacturer
- See official notice
- Lot number
- numbers, 25ZF0500
- Batch number
- numbers, 25ZF0500
- Date code
- dates, Date
- Expiration date
- dates, Date
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
Classification Class III Reason for the Action The vial label of some batches of Optiray 350 100 mL vials is incorrect. It lists the ingredients' quantities for Optiray 350 75 mL vial instead. The ingredients' quantities listed on the product carton are accurate. Instructions for Customers/Users Customers are to: - Refer to the product carton for the correct ingredients' quantities. - Continue to administer the product in accordance with the Product Information (PI). Action Commencement Date 3/08/2026 Responsible Entity Guerbet Australia Pty Ltd
Hazard
Classification Class III Reason for the Action The vial label of some batches of Optiray 350 100 mL vials is incorrect. It lists the ingredients' quantities for Optiray 350 75 mL vial instead. The ingredients' quantities listed on the product carton are accurate. Instructions for Customers/Users Customers are to: - Refer to the product carton for the correct ingredients' quantities. - Continue to administer the product in accordance with the Product Information (PI). Action Commencement Date 3/08/2026 Responsible Entity Guerbet Australia Pty Ltd
Official recall notice
OPTIRAY 350 Ioversol 74% w/v 74.1g/100mL Injection Vial
Agency: Therapeutic Goods Administration
Official publication date: August 3, 2026
Read the official AU_TGA_DRAC recall notice →Scan products you own
Scan products you own once and let RecallGuard monitor future official recalls.
Scan & Monitor Products