Recall: D-0543-2025

Class II - Potentially Harmful

Class IIClassification

2025-07-05Initiated

OngoingStatus

FDC LimitedFirm

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.

Reason

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

Distribution

U.S Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.