Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Ketorolac Tromethamine Ophthalmic Solution Recalled by Apotex Corp. Due to Lack of Assurance of Sterility; atypical weight loss...

Date: September 5, 2025
Company: Apotex Corp.
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Apotex Corp. directly.

Affected Products

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.

Quantity: 493,468 bottles

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Apotex Corp.

Apotex Corp. has 30 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report