FDA Drug · D-0494-2025

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2

Class II · Ongoing

Lack of Assurance of Sterility

Affected lots / codes — check yours against thisBatch TZ1236, Exp Date: 11/30/2025

Recalling firm: Apotex Corp., Weston, FL
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 87,840 bottles
Distribution: US Nationwide.
Recall initiated: May 28, 2025
Classified: June 25, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0494-2025%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

Check this brand across all 8 databases →