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 Mayne Pharma Usa 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 Mayne Pharma Usa directly.
Affected Products
Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505
Quantity: a) 52034 bottles and b) 22074 bottles
Why Was This Recalled?
Lack of Assurance of Sterility: Failed preservative effectiveness test
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mayne Pharma Usa
Mayne Pharma Usa has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report