Apotex Recalls Ketorolac Tromethamine Ophthalmic Solution Over Sterility Concerns

Apotex Corp. has voluntarily initiated a Class II recall of ketorolac tromethamine ophthalmic solution, 0.5% (5 mL), following concerns over product sterility. The affected lots—VA0444, VA4608, and TZ7016—carry expiration dates of December 2025 and January 2026. Manufactured by Apotex Inc. in Richmond Hill, Ontario, and distributed by the company’s US affiliate in Weston, Florida, the product was shipped nationwide. In total, 493 468 bottles are included in the recall, each labeled under NDC 60505-1003-1 and sold as a sterile, prescription-only ophthalmic solution.

The recall, classified by the US Food and Drug Administration (FDA) as Class II on September 30, 2025, stems from a lack of assurance of sterility due to improper bottle sealing, which caused atypical weight loss in some bottles. Although no adverse events have been reported, the defect could compromise product sterility, posing a potential risk of eye infection or other complications. Apotex began the recall process on September 5, 2025, notifying consignees through direct letters. The recall remains ongoing, and no press release has been issued to the public at this time.

Ketorolac tromethamine ophthalmic solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the temporary relief of ocular itching caused by seasonal allergic conjunctivitis and for the treatment of postoperative inflammation following cataract extraction. Pharmacists are encouraged to verify product lot numbers in their inventory and advise patients to discontinue use of affected bottles to prevent potential exposure to nonsterile medication.

Reference

FDA. Enforcement Report. October 8, 2025. Accessed October 8, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=215927