Recall: D-0677-2025

Class II - Potentially Harmful

Class IIClassification

2025-09-05Initiated

OngoingStatus

Apotex Corp.Firm

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.

Reason

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

Distribution

Nationwide in the US

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.