Apotex Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution lacks assurance of sterility.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Apotex Corp. of Weston, Florida, recalled Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%, 5 mL, Rx Only, Sterile, due to lack of assurance of sterility. The company began the recall on March 5, 2026, and the FDA added it to the Enforcement Report on March 16, 2026. The product was distributed nationwide in the U.S.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%
- NDC
- 60505-0589-1
- Lot
- VJ8599
Details
- Company began the recall
- Sold in
U.S. Nationwide
- Event ID
- 98536
- Recall No.
- D-0407-2026
- Company
- Apotex Corp.Weston, Florida
- Hazard
- Sterility failure
- Quantity recalled
- 107,136 vials
Company began the recall
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Classified by FDA
Listed on Recall Canary
Summary updated
