FDC Limited: Drug Recall

Recall #D-0543-2025 · 07/05/2025

Class II: Risk

Recall Details

Recall Number: D-0543-2025
Classification: Class II
Product Type: Drug
Recalling Firm: FDC Limited
Status: Ongoing
Date Initiated: 07/05/2025
Location: Aurangabad, Maharashtra State, India
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 154,176 bottles

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 Pattern

U.S Nationwide.

Other Recalls by FDC Limited

Class II: Risk 04/18/2025

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.
Class II: Risk 03/11/2025

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
Class II: Risk 01/23/2025

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.
Class II: Risk 12/16/2024

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
Class II: Risk 12/05/2024

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.

View all recalls by FDC Limited →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.