FDAClass IIJuly 2, 2025

Brimonidine Tartrate/Timolol Maleate Ophthalmic recall: Sterility Concern

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada…

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?

Batch VC6058, Exp Date: 10/31/2025

Product
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada…
Recalling firm
Apotex Corp.
Quantity
6,288 Bottles
Distribution
US Nationwide.
Recall date
July 2, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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