--- title: "FDC Limited Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search FDC Limited recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/fdc-limited/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # FDC Limited recall records **10** reported ongoing 11 records in this archive. Latest source date Jul 5, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jul 5, 2025 FDA drug enforcement ### [Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmac...](https://isitonrecall.com/recall/fda-drug-d-0543-2025-timolol-maleate-ophthalmic-solution-usp-0-5-sterile-5ml-bottles-rx-only-manufactured-by-fdc-limited/) Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. Class II Reported ongoing Distribution: U.S Nationwide. [Official source for Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FD...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0543-2025%22) Apr 18, 2025 FDA drug enforcement ### [Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharma...](https://isitonrecall.com/recall/fda-drug-d-0403-2025-timolol-maleate-ophthalmic-solution-usp-0-5-sterile-10ml-bottles-rx-only-manufactured-by-fdc-limited/) 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 Reported ongoing Distribution: U.S. Nationwide [Official source for Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: F...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0403-2025%22) Mar 11, 2025 FDA drug enforcement ### [Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharasht...](https://isitonrecall.com/recall/fda-drug-d-0282-2025-ciprofloxacin-ophthalmic-solution-usp-0-3-as-base-package-in-5-ml-bottles-rx-only-distributed-by-lea/) 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 Reported ongoing Distribution: Nationwide in the U.S [Official source for Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distribute...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0282-2025%22) Jan 23, 2025 FDA drug enforcement ### [Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmac...](https://isitonrecall.com/recall/fda-drug-d-0214-2025-timolol-maleate-ophthalmic-solution-usp-0-5-sterile-5ml-bottles-rx-only-manufactured-by-fdc-limited/) 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 Reported ongoing Distribution: Distributed to one (1) Us Distributor in NJ [Official source for Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FD...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0214-2025%22) Dec 16, 2024 FDA drug enforcement ### [Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, ...](https://isitonrecall.com/recall/fda-drug-d-0182-2025-ciprofloxacin-ophthalmic-solution-usp-0-3-as-base-sterile-package-in-5-ml-bottles-rx-only-distribute/) 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 Reported ongoing Distribution: Nationwide [Official source for Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, D...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0182-2025%22) Dec 5, 2024 FDA drug enforcement ### [Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharm...](https://isitonrecall.com/recall/fda-drug-d-0114-2025-timolol-maleate-ophthalmic-solution-usp-0-25-sterile-15ml-bottles-rx-only-manufactured-by-fdc-limite/) 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 Reported ongoing Distribution: Distributed to one Us Distributor in NJ. [Official source for Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0114-2025%22) Oct 29, 2024 FDA drug enforcement ### [Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmac...](https://isitonrecall.com/recall/fda-drug-d-0035-2025-timolol-maleate-ophthalmic-solution-usp-0-5-sterile-5ml-bottles-rx-only-manufactured-by-fdc-limited/) 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 Reported ongoing Distribution: Distributed to one Us Distributor in NJ. [Official source for Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FD...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0035-2025%22) Aug 12, 2024 FDA drug enforcement ### [Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj...](https://isitonrecall.com/recall/fda-drug-d-0642-2024-timolol-maleate-ophthalmic-solution-usp-0-5-packaged-in-a-5ml-bottle-ndc-64980-514-05-and-b-10ml-bot/) Defective Container: patients are 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 Reported ongoing Distribution: Nationwide U.S.A. [Official source for Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0642-2024%22) Jul 23, 2024 FDA drug enforcement ### [Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, ...](https://isitonrecall.com/recall/fda-drug-d-0623-2024-ciprofloxacin-ophthalmic-solution-usp-0-3-as-base-package-in-bottles-a-10-ml-ndc-69315-308-10-b-2-5/) 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 Reported ongoing Distribution: U.S. A. Nationwide [Official source for Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0623-2024%22) Jul 18, 2024 FDA drug enforcement ### [Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmac...](https://isitonrecall.com/recall/fda-drug-d-0632-2024-timolol-maleate-ophthalmic-solution-usp-0-5-sterile-5ml-bottles-rx-only-manufactured-by-fdc-limited/) Defective container; yellow colored spike from cap lodged in the nozzle Class II Reported ongoing Distribution: Nationwide in the US [Official source for Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FD...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0632-2024%22) Apr 25, 2024 FDA drug enforcement ### [Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Ma...](https://isitonrecall.com/recall/fda-drug-d-0488-2024-timolol-maleate-ophthalmic-solution-usp-0-5-packaged-in-a-5ml-bottles-ndc-64980-514-05-and-b-15-ml-b/) Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers. Class II Reported terminated Distribution: New Jersey Only [Official source for Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), an...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0488-2024%22) ## Reasons in these listed records - Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. - 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. - 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 - 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 These examples come from this result page and are not a ranking of every recall reason. ## Checking FDC Limited ### Is there a recall on fdc limited right now? This archive contains 11 records, including 10 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search FDC Limited](https://isitonrecall.com/check/?q=FDC%20Limited) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)