Class II

Drug Recall: 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 Jerse

FDC Limited · July 5, 2025

Reason for Recall

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

Product Description

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.

Distribution

U.S Nationwide.

States Affected

NATIONWIDE

Quantity Affected

154,176 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0543-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.