Home / Recalls / FDC Limited / D-0543-2025

D-0543-2025 Class II Ongoing

Recalled by FDC Limited — Aurangabad, Maharashtra State

Recall Details

Product Type
Drugs
Report Date
August 6, 2025
Initiation Date
July 5, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
154,176 bottles

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.

Reason for Recall

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

Distribution Pattern

U.S Nationwide.

Code Information

Lot#: 083L061, Exp.: 11/2025.

Other recalls by FDC Limited

  • D-0403-2025 Class II — Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, M (April 18, 2025)
  • D-0282-2025 Class II — Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx (March 11, 2025)
  • D-0214-2025 Class II — Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Ma (January 23, 2025)
  • D-0182-2025 Class II — Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bo (December 16, 2024)
  • D-0114-2025 Class II — Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, (December 5, 2024)
  • D-0035-2025 Class II — Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Ma (October 29, 2024)
  • D-0642-2024 Class II — Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 6 (August 12, 2024)
  • D-0623-2024 Class II — Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 m (July 23, 2024)
  • D-0632-2024 Class II — Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Ma (July 18, 2024)
  • D-0488-2024 Class II — Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC (April 25, 2024)