Overview
- Anvisa published Resolução-RE nº 2.820 on July 17, 2026, formally suspending import of Zonidra 20 mg/mL and all ophthalmic products manufactured by France’s Excelvision.
- The French regulator ANSM inspected Excelvision from June 3–5, 2026 and found breaches of good manufacturing practices that led France to suspend the company’s aseptic activities.
- Anvisa specifically suspended all lots of Hyabak and Thealiz Duo produced at Excelvision from June 5, 2026 onward, citing the June ANSM findings as the trigger for its preventive action.
- Consumers are advised not to use affected products, to check packaging for the place of manufacture and to contact suppliers or the company if they have concerns; authorities may require recalls if affected lots are found in Brazil.
- The measure rests on Brazil’s health rules and an administrative process signed by Renata de Lima Soares, and it could prompt checks of other brands that source collyriums and gels from Excelvision.