Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0 recalled over sterility concerns

Recall date

March 5, 2026

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%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured…

Recall number

D-0407-2026

FDA classification

Class II

Brand / firm

Apotex Corp.

Sold / distributed

U.S. 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%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.