DrugAug 6, 2025
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles recall — FDA D-0543-2025
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Class IIFDA: OngoingFDC Limited
Recall history in this database
Classification mix: Class II: 9.
DrugMay 14, 2025
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles recall — FDA D-0403-2025
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class IIFDA: OngoingFDC Limited
DrugMar 26, 2025
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles recall — FDA D-0282-2025
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class IIFDA: OngoingFDC Limited
DrugFeb 12, 2025
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles recall — FDA D-0214-2025
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class IIFDA: OngoingFDC Limited
DrugJan 15, 2025
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles recall — FDA D-0182-2025
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class IIFDA: OngoingFDC Limited
DrugDec 18, 2024
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles recall — FDA D-0114-2025
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class IIFDA: OngoingFDC Limited
DrugNov 13, 2024
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles recall — FDA D-0035-2025
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class IIFDA: OngoingFDC Limited
DrugAug 28, 2024
Timolol Maleate Ophthalmic Solution USP, 0.5% recall — FDA D-0642-2024
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class IIFDA: OngoingFDC Limited
DrugAug 21, 2024
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles recall — FDA D-0632-2024
Defective container; yellow colored spike from cap lodged in the nozzle
Class IIFDA: OngoingFDC Limited
Understanding this recall history
This page summarizes recall records in which the official source identifies FDC Limited as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.