FDC Limited: 11 recalls on record

Recalls filed with 1 agency: FDA (11).

First recall on record: May 15, 2024. Most recent: August 6, 2025.

Risk classification: Class II: 11

Most recent recalls

DateAgencyProduct
August 6, 2025FDATimolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufacture…D-0543-2025
May 14, 2025FDATimolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactur…D-0403-2025
March 26, 2025FDACiprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Di…D-0282-2025
February 12, 2025FDATimolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufacture…D-0214-2025
January 15, 2025FDACiprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx…D-0182-2025
December 18, 2024FDATimolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactu…D-0114-2025
November 13, 2024FDATimolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufacture…D-0035-2025
August 28, 2024FDATimolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-…D-0642-2024
August 21, 2024FDATimolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufacture…D-0632-2024
August 7, 2024FDACiprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69…D-0623-2024
May 15, 2024FDATimolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514…D-0488-2024

Questions about this company

How many recalls does FDC Limited have?
Recalert has 11 U.S. recalls on record for FDC Limited, published between May 15, 2024 and August 6, 2025.
What was the most recent FDC Limited recall?
FDA recall D-0543-2025, published August 6, 2025: 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 Jers…
Which agencies have handled FDC Limited recalls?
FDC Limited appears as the recalling firm in recalls from: FDA (11).

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