FDC Limited: Drug Recall

Recall #D-0403-2025 · 04/18/2025

Class II: Risk

Recall Details

Recall Number: D-0403-2025
Classification: Class II
Product Type: Drug
Recalling Firm: FDC Limited
Status: Ongoing
Date Initiated: 04/18/2025
Location: Aurangabad, Maharashtra State, N/A, India
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 60428 bottles

Reason for Recall

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.

Product Description

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.

Distribution Pattern

U.S. Nationwide

Other Recalls by FDC Limited

Class II: Risk 07/05/2025

Defective Container: spike of the cap becomes 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.