Ketorolac Tromethamine Ophthalmic Solution recalled over sterility concerns

Recall date

September 5, 2025

Source

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

Official notice title

Apotex Corp. recalls Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill,…

Recall number

D-0677-2025

FDA classification

Class II

Brand / firm

Apotex Corp.

Sold / distributed

Nationwide in the US

Why it was recalled

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

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

What was recalled

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.