FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aura
Recalled May 14, 2025 · FDA recall D-0403-2025 · FDC
Hazard
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. · FDA Class II
Units
60428 bottles
Sold at
U.S. Nationwide
Description
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.
Product
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.
Manufacturer(s)
FDC Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →