Apotex Corp. is recalling 493,468 bottles of Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Rx Only, sterile, distributed nationwide in the United States. The recall cites lack of assurance of sterility due to improper bottle sealing. Consumers and healthcare providers should stop using the product immediately and contact Apotex Corp. or their healthcare provider for guidance.
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Consumers and healthcare providers should stop using this product immediately. Contact Apotex Corp. or your healthcare provider for guidance. Notification method: Letter
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Ketorolac Tromethamine Ophthalmic Solution is a sterile eye drop used to treat eye pain and inflammation. The product is sold as a prescription medicine and distributed nationwide.
A lack of sterility can allow microbial contamination, potentially causing eye infections or other complications in patients.
This recall is not described as part of a broader industry pattern.
Patients with affected bottles may be exposed to contaminated solution. The risk is primarily eye infection which could require medical treatment.
Review the FDA recall page for D-0677-2025 and Apotex recall notice for batch and disposal instructions.
No specific refund or replacement timeline is provided in the recall notice. Follow official guidance for disposal or replacement; expect updates from
Keep the recall letter, product packaging, batch numbers, and purchase receipts. Document all communications with the manufacturer and healthcare providers.
Product: Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL. NDC 60505-1003-1. Manufactured by Apotex Inc., Richmond Hill, Ontario, Canada. Manufactured for Apotex Corp., Weston, FL 33326. Batch numbers: VA0444, VA4608, TZ7016. Expiry: VA0444/VA4608 01/2026; TZ7016 12/2025. UPC: Bottles 360505100316; Bottles UPC on bottle: (01)0(03)60505100316. Quantity: 493,468 bottles. Distribution: Nationwide in the United States. Sold as Rx Only.
No injuries or incidents have been reported.
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