FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Auran
Recalled August 6, 2025 · FDA recall D-0543-2025 · FDC
Hazard
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. · FDA Class II
Units
154,176 bottles
Sold at
U.S Nationwide.
Description
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Product
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
Manufacturer(s)
FDC Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →