Timolol recalls

The FDA has published 11 recalls involving Timolol since 2020. The latest was reported on 6 Aug 2025. Most were for sterility. 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 recalls11since 2020

Last 12 months0reported

Class I00% of total

Ongoing7latest 6 Aug 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 1 1 0Jan '25 1 0 0Apr 1 0 0Jul 1 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 9 82%Class III 2 18%

Why timolol is recalled

Sterility982%
Packaging Defects218%

Companies

Brands

Timolol Maleate1091%
Betimol19%

By year

2025327%
2024655%
2020218%

Ongoing timolol recalls

7 active

Reported	Class	Recall	Company	Reason	Where
6 Aug 2025Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol Maleate	FDC	Sterility	Nationwide
14 May 2025Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol Maleate	FDC	Sterility	Nationwide
12 Feb 2025Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol Maleate	FDC	Sterility	NJ
18 Dec 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 25%, Sterile recalled by FDCTimolol Maleate	FDC	Sterility	NJ
13 Nov 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol Maleate	FDC	Sterility	NJ
28 Aug 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution recalled by FDCTimolol Maleate	FDC	Packaging Defects	Nationwide

All timolol recalls, newest first

11 total

Reported	Class	Recall	Company	Reason	Where
6 Aug 2025Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol Maleate	FDC	Sterility	Nationwide
14 May 2025Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol Maleate	FDC	Sterility	Nationwide
12 Feb 2025Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol Maleate	FDC	Sterility	NJ
18 Dec 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 25%, Sterile recalled by FDCTimolol Maleate	FDC	Sterility	NJ
13 Nov 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol Maleate	FDC	Sterility	NJ
28 Aug 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution recalled by FDCTimolol Maleate	FDC	Packaging Defects	Nationwide
21 Aug 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol Maleate	FDC	Sterility	Nationwide
15 May 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution recalled by FDCTimolol Maleate	FDC	Packaging Defects	NJ
20 Mar 2024Drug	CLASS II	Betimol (timolol ophthalmic solution) recalled by Thea PharmaBetimol	Thea Pharma	Sterility	Nationwide
1 Jul 2020Drug	CLASS III	Timolol Maleate Sterile Opthalmic Solution recalledTimolol Maleate	Rising Pharmaceuticals	Sterility	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.