Generic drug makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IndiaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list FDC Limited with 14 drug applications and 11 drug recalls. The most recent is a drug recall dated Jul 5, 2025: Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactur….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 5, 2025 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, Class II · Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. | Drug recalls |
| Apr 18, 2025 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra,Class II · Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of th | Drug recalls |
| Mar 11, 2025 | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. MaClass II · Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of th | Drug recalls |
| Jan 23, 2025 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, Class II · Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of th | Drug recalls |
| Dec 16, 2024 | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, FairfielClass II · Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of th | Drug recalls |
| Dec 5, 2024 | Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, MaharashtraClass II · Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of th | Drug recalls |
| Oct 29, 2024 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, Class II · Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of th | Drug recalls |
| Aug 12, 2024 | 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 onlyClass II · Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the | Drug recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
