FDAClass IIMarch 25, 2026

Brimonidine Tartrate/Timolol Maleate Ophthalmic 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…

Why was Brimonidine Tartrate/Timolol Maleate Ophthalmic recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027

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 date
March 25, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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