Could cause temporary or reversible harm; serious harm is unlikely.
Lack of Assurance of Sterility
| Brand name | BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION |
| Generic name | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE |
| Active ingredient(s) | BRIMONIDINE TARTRATE, TIMOLOL MALEATE |
| Distributed by / for | Apotex Corp., Weston, FL 33326 |
| NDC | 60505-0589-1 |
| Full product label | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1. |
| Recalling firm | Apotex Corp. |
| Distribution | U.S. Nationwide |
| Quantity | 107,136 vials |
| Recall initiated | 2026-03-05 |
| Report date | 2026-03-25 |
| Recall completed | — |
| Recall number | D-0407-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Weston FL United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗