Apotex Corp. recalls Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, O
Recalled October 8, 2025 · FDA recall D-0677-2025 · Apotex
Hazard
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns · FDA Class II
Units
493,468 bottles
Sold at
Nationwide in the US
Description
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Product
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.
Manufacturer(s)
Apotex Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →