FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aura…

Recall date

July 5, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0543-2025

FDA classification

Class II

Brand / firm

FDC Limited

Sold / distributed

U.S Nationwide.

Why it was recalled

Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.