Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5% Recall: Sterility Concern
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Brimonidine Tartrate/Timolol Maleate Ophthalmic recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
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.
Which lot codes, UPCs or models are affected?
Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027
- Agency record number
- D-0407-2026
- Product
- Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL…
- Recalling firm
- Apotex Corp.
- Quantity
- 107,136 vials
- Distribution
- U.S. Nationwide
- Recall started
- March 5, 2026
- Report date
- March 25, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)