Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bromfenac Ophthalmic Solution 0.09% Recalled by Apotex Inc. Due to Lack of Assurance of Sterility: Failed preservative effectiveness...
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 Inc. directly.
Affected Products
Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.
Quantity: 5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532)
Why Was This Recalled?
Lack of Assurance of Sterility: Failed preservative effectiveness testing
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Apotex Inc.
Apotex Inc. has 41 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report