Timolol Maleate recalls

Timolol Maleate products have been recalled 10 times, most recently on 6 Aug 2025. The recalling company is usually FDC. The most common reason is sterility.

Total recalls10since 2020
Last 12 months0reported
Class I00% of total
Ongoing7latest 6 Aug 2025

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 8 80%Class III 2 20%

Why timolol maleate is recalled

Companies

Product types

By year

Ongoing timolol maleate recalls

7 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 IITimolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol MaleateFDCSterilityNJ
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

All timolol maleate recalls, newest first

10 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 IITimolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol MaleateFDCSterilityNJ
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 IITimolol Maleate Ophthalmic Solution recalled by FDCTimolol MaleateFDCPackaging DefectsNJ
DrugCLASS IIITimolol Maleate Sterile Opthalmic Solution recalledTimolol MaleateRising PharmaceuticalsSterilityNationwide
DrugCLASS IIITimolol Maleate USP, 5%, Sterile Opthalmic Solution recalledTimolol MaleateRising PharmaceuticalsSterilityNationwide

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.