Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalled over sterility concerns

Recall date

May 28, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Apotex Corp. recalls Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex I…

Recall number

D-0496-2025

FDA classification

Class II

Brand / firm

Apotex Corp.

Sold / distributed

US Nationwide.

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3