Timolol maleate ophthalmic recalls
The FDA has published 5 recalls involving Timolol maleate ophthalmic since 2021. The latest was reported on 7 Jun 2023. Most were for sterility. Akorn 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 recalls5since 2021
Last 12 months0reported
Class I00% of total
Ongoing3latest 7 Jun 2023
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 3 60%Class III 2 40%
Why timolol maleate ophthalmic is recalled
Companies
By year
Ongoing timolol maleate ophthalmic recalls
3 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Akorn | Akorn | Sterility | Nationwide |
| Drug | CLASS III | Timolol Maleate Ophthalmic Solution, USP, 5%, mL Single-Dose Vials recalled | Akorn | Sterility | Nationwide |
All timolol maleate ophthalmic recalls, newest first
5 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Akorn | Akorn | Sterility | Nationwide |
| Drug | CLASS III | Timolol Maleate Ophthalmic Solution recalled by Apotex | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS III | Timolol Maleate Ophthalmic Solution, USP, 5%, mL Single-Dose Vials recalled | Akorn | Sterility | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Cardinal Health | Cardinal Health | Sterility | FL, GA, SC |
Should you stop taking Timolol maleate ophthalmic?
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.