Brimonidine recalls

The FDA has published 4 recalls involving Brimonidine since 2020. The latest was reported on 15 Mar 2023. Most were for foreign material. Somerset Therapeutics 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 recalls4since 2020

Last 12 months0reported

Class I00% of total

Ongoing0latest 15 Mar 2023

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 1 25%Class III 3 75%

Why brimonidine is recalled

Foreign Material375%
Sterility125%

Companies

Somerset Therapeutics375%
Apotex125%

By year

2023125%
2020375%

All brimonidine recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
15 Mar 2023Drug	CLASS II	Brimonidine Tartrate Ophthalmic Solution recalled by ApotexBrimonidine Tartrate	Apotex	Sterility	Nationwide
15 Jul 2020Drug	CLASS III	Brimonidine Tartrate Opthalmic Solution recalledBrimonidine Tartrate	Somerset Therapeutics	Foreign Material	Nationwide
15 Jul 2020Drug	CLASS III	Brimonidine Tartrate Opthalmic Solution recalledBrimonidine Tartrate	Somerset Therapeutics	Foreign Material	Nationwide
15 Jul 2020Drug	CLASS III	Brimonidine Tartrate Opthalmic Solution recalledBrimonidine Tartrate	Somerset Therapeutics	Foreign Material	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.