Timolol Maleate recalls

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

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

1Nov '24 1 0 1Feb 0 0 1May 0 0 1Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

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

Why timolol maleate is recalled

Companies

FDC880%
Rising Pharmaceuticals220%

Product types

Eye Drops10100%

By year

2025330%
2024550%
2020220%

Ongoing timolol maleate recalls

7 active

Reported	Class	Recall	Company	Reason	Where
6 Aug 2025Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate	FDC	Other	Nationwide
14 May 2025Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate	FDC	Other	Nationwide
12 Feb 2025Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate	FDC	Other	NJ
18 Dec 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile recalled by FDCTimolol Maleate	FDC	Other	NJ
13 Nov 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate	FDC	Other	NJ
28 Aug 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution recalled by FDCTimolol Maleate	FDC	Packaging Defects	Nationwide

All timolol maleate recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
6 Aug 2025Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate	FDC	Other	Nationwide
14 May 2025Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate	FDC	Other	Nationwide
12 Feb 2025Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate	FDC	Other	NJ
18 Dec 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile recalled by FDCTimolol Maleate	FDC	Other	NJ
13 Nov 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate	FDC	Other	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, 0.5%, Sterile recalled by FDCTimolol Maleate	FDC	Other	Nationwide
15 May 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution recalled by FDCTimolol Maleate	FDC	Packaging Defects	NJ
1 Jul 2020Drug	CLASS III	Timolol Maleate Sterile Opthalmic Solution recalledTimolol Maleate	Rising Pharmaceuticals	Sterility	Nationwide
1 Jul 2020Drug	CLASS III	Timolol Maleate USP, 0.5%, Sterile Opthalmic Solution recalledTimolol Maleate	Rising Pharmaceuticals	Sterility	Nationwide

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.