FDC recalls

FDC has 11 recalls on record with the FDA and USDA, the earliest in 2024 and the latest reported on 6 Aug 2025. 10 are still ongoing. The most frequent reason is sterility.

Total recalls11since 2024
Last 12 months0reported
Class I00% of total
Ongoing10latest 6 Aug 2025

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 11 100%Class III 0 0%

Why fdc is recalled

Product types

Brands

By year

Ongoing fdc recalls

10 active
ReportedClassRecallCompanyReasonWhere
DrugCLASS IITimolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol MaleateFDCSterilityNationwide
DrugCLASS IITimolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol MaleateFDCSterilityNationwide
DrugCLASS IICiprofloxacin Ophthalmic Solution USP, 3% as base, package recalledCiprofloxacinFDCPackaging DefectsNationwide
DrugCLASS IITimolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol MaleateFDCSterilityNJ
DrugCLASS IICiprofloxacin Ophthalmic Solution USP, 3% as base, Sterile, package recalledCiprofloxacinFDCSterilityNationwide
DrugCLASS IITimolol Maleate Ophthalmic Solution USP, 25%, Sterile recalled by FDCTimolol MaleateFDCSterilityNJ

All fdc recalls, newest first

11 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IITimolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol MaleateFDCSterilityNationwide
DrugCLASS IITimolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol MaleateFDCSterilityNationwide
DrugCLASS IICiprofloxacin Ophthalmic Solution USP, 3% as base, package recalledCiprofloxacinFDCPackaging DefectsNationwide
DrugCLASS IITimolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol MaleateFDCSterilityNJ
DrugCLASS IICiprofloxacin Ophthalmic Solution USP, 3% as base, Sterile, package recalledCiprofloxacinFDCSterilityNationwide
DrugCLASS IITimolol Maleate Ophthalmic Solution USP, 25%, Sterile recalled by FDCTimolol MaleateFDCSterilityNJ
DrugCLASS IITimolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol MaleateFDCSterilityNJ
DrugCLASS IITimolol Maleate Ophthalmic Solution recalled by FDCTimolol MaleateFDCPackaging DefectsNationwide
DrugCLASS IITimolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol MaleateFDCSterilityNationwide
DrugCLASS IICiprofloxacin ophthalmic solution USP, 3% as base recalled by FDCCiprofloxacinFDCPackaging DefectsNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.