Brimonidine recalls

The FDA has published 9 recalls involving Brimonidine since 2017. The latest was reported on 25 Mar 2026. Most were for potency & assay. Apotex 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 recalls9since 2017

Last 12 months1reported

Class I00% of total

Ongoing3latest 25 Mar 2026

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 5 56%Class III 4 44%

Why brimonidine is recalled

Companies

Brands

By year

2026111%
2025222%
2023111%
2020333%
2019111%
2017111%

Ongoing brimonidine recalls

3 active

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide
8 Oct 2025Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide
2 Jul 2025Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5% recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide

All brimonidine recalls, newest first

9 total

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide
8 Oct 2025Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide
2 Jul 2025Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5% recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide
15 Mar 2023Drug	CLASS II	Brimonidine Tartrate Ophthalmic Solution recalled by Apotex	Apotex	Sterility	Nationwide
15 Jul 2020Drug	CLASS III	Brimonidine Tartrate Opthalmic Solution recalledBrimonidine Tartrate	Somerset Therapeutics	Potency & Assay	Nationwide
15 Jul 2020Drug	CLASS III	Brimonidine Tartrate Opthalmic Solution recalledBrimonidine Tartrate	Somerset Therapeutics	Potency & Assay	Nationwide
15 Jul 2020Drug	CLASS III	Brimonidine Tartrate Opthalmic Solution recalledBrimonidine Tartrate	Somerset Therapeutics	Potency & Assay	Nationwide
3 Apr 2019Drug	CLASS II	Combigan (brimonidine tartrate/timolol maleate ophthalmic recalledCombigan	Allergan Sales	Manufacturing (CGMP) Deviations	TN
22 Nov 2017Drug	CLASS III	Combigan (brimonidine tartrate/timolol maleate ophthalmic recalledCombigan	Allergan Sales	Potency & Assay	Nationwide

Should you stop taking Brimonidine?

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.