Fdc recalls
Fdc appears in 11 official U.S. recall notices indexed by RecallRadar, most recently on 2025-08-06.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 11 |
|---|---|
| Published | 2024-05-15 to 2025-08-06 |
| By agency | FDA Drug (11) |
| By classification | Class II (11) |
| By status | ongoing (10), terminated (1) |
| Distribution named in notices | NJ, US |
Recalls
- Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra,…
FDA Drug · Class II · 2025-08-06 · Fdc
Reason: Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. - Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra…
FDA Drug · Class II · 2025-05-14 · Fdc
Reason: 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. - Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. M…
FDA Drug · Class II · 2025-03-26 · Fdc
Reason: 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 - Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra,…
FDA Drug · Class II · 2025-02-12 · Fdc
Reason: 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. - Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfie…
FDA Drug · Class II · 2025-01-15 · Fdc
Reason: 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 - Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtr…
FDA Drug · Class II · 2024-12-18 · Fdc
Reason: 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. - Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra,…
FDA Drug · Class II · 2024-11-13 · Fdc
Reason: 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 - 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 onl…
FDA Drug · Class II · 2024-08-28 · Fdc
Reason: 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. - Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra,…
FDA Drug · Class II · 2024-08-21 · Fdc
Reason: Defective container; yellow colored spike from cap lodged in the nozzle - 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…
FDA Drug · Class II · 2024-08-07 · Fdc
Reason: 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. - 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…
FDA Drug · Class II · 2024-05-15 · Fdc
Reason: Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.