Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recall (Apotex Corp.)
DrugClass IIOngoing
Summary: Apotex Corp. is recalling 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.. Reason: Lack of Assurance of Sterility.
What is being recalled
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.
Why
Lack of Assurance of Sterility
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide
How to tell if yours is affected
Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0407-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 5, 2026 |
| Reported | March 25, 2026 |
| Company | Apotex Corp. |
| Company location | Weston, FL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 107,136 vials |
More recalls from Apotex Corp. · all drug recalls · recalls from March 2026