Timolol recalls
The FDA has published 20 recalls involving Timolol since 2014. The latest was reported on 6 Aug 2025. Most were for potency & assay. FDC has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls 20 since 2014
Last 12 months 0 reported
Class I 0 0% of total
Ongoing 10 latest 6 Aug 2025
Recalls per month, last 24 months click a bar for that month Severity split
0 0%12 60%8 40%
Ongoing timolol recalls 10 active Reported Class Recall Company Reason Where 6 Aug 2025 Drug CLASS II Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDC Timolol Maleate FDC Other Nationwide 14 May 2025 Drug CLASS II Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDC Timolol Maleate FDC Other Nationwide 12 Feb 2025 Drug CLASS II Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDC Timolol Maleate FDC Other NJ 18 Dec 2024 Drug CLASS II Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile recalled by FDC Timolol Maleate FDC Other NJ 13 Nov 2024 Drug CLASS II Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDC Timolol Maleate FDC Other NJ 28 Aug 2024 Drug CLASS II Timolol Maleate Ophthalmic Solution recalled by FDC Timolol Maleate FDC Packaging Defects Nationwide
All timolol recalls, newest first 20 total Reported Class Recall Company Reason Where 6 Aug 2025 Drug CLASS II Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDC Timolol Maleate FDC Other Nationwide 14 May 2025 Drug CLASS II Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDC Timolol Maleate FDC Other Nationwide 12 Feb 2025 Drug CLASS II Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDC Timolol Maleate FDC Other NJ 18 Dec 2024 Drug CLASS II Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile recalled by FDC Timolol Maleate FDC Other NJ 13 Nov 2024 Drug CLASS II Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDC Timolol Maleate FDC Other NJ 28 Aug 2024 Drug CLASS II Timolol Maleate Ophthalmic Solution recalled by FDC Timolol Maleate FDC Packaging Defects Nationwide 21 Aug 2024 Drug CLASS II Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDC Timolol Maleate FDC Other Nationwide 15 May 2024 Drug CLASS II Timolol Maleate Ophthalmic Solution recalled by FDC Timolol Maleate FDC Packaging Defects NJ 20 Mar 2024 Drug CLASS II Betimol (timolol ophthalmic solution) recalled by Thea Pharma Betimol Thea Pharma Sterility Nationwide 7 Jun 2023 Drug CLASS II Timolol Maleate Ophthalmic Solution recalled by Akorn Akorn Potency & Assay Nationwide 25 Jan 2023 Drug CLASS II Timolol Maleate Ophthalmic Solution recalled by Akorn Akorn Manufacturing (CGMP) Deviations Nationwide 4 Jan 2023 Drug CLASS III Timolol Maleate Ophthalmic Solution recalled by Apotex Apotex Potency & Assay Nationwide 7 Sep 2022 Drug CLASS III Timolol Maleate Ophthalmic Solution, USP, 0.5%, . Single-Dose Vials recalled Akorn Potency & Assay Nationwide 2 Jun 2021 Drug CLASS II Timolol Maleate Ophthalmic Solution recalled by Cardinal Health Cardinal Health Manufacturing (CGMP) Deviations FL, GA, SC 1 Jul 2020 Drug CLASS III Timolol Maleate Sterile Opthalmic Solution recalled Timolol Maleate Rising Pharmaceuticals Sterility Nationwide 1 Jul 2020 Drug CLASS III Timolol Maleate USP, 0.5%, Sterile Opthalmic Solution recalled Timolol Maleate Rising Pharmaceuticals Sterility Nationwide 12 Feb 2014 Drug CLASS III Timolol Maleate Sterile Ophthalmic Solution, USP 0.25% recalled Pack Pharmaceuticals Potency & Assay Nationwide 12 Feb 2014 Drug CLASS III Timolol Maleate Sterile Ophthalmic Solution, USP 0.25% recalled Pack Pharmaceuticals Potency & Assay Nationwide 12 Feb 2014 Drug CLASS III Timolol Maleate Sterile Ophthalmic Solution, USP 0.5% recalled Pack Pharmaceuticals Potency & Assay Nationwide 12 Feb 2014 Drug CLASS III Timolol Maleate Sterile Ophthalmic Solution, USP 0.5% recalled Pack Pharmaceuticals Potency & Assay Nationwide
Should you stop taking Timolol?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.