Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BromSite (bromfenac ophthalmic solution) 0.075% Recalled by Sun Pharmaceutical Industries, Inc. Due to Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may...
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 Sun Pharmaceutical Industries, Inc. directly.
Affected Products
BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41
Quantity: 69840 bottles
Why Was This Recalled?
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical Industries, Inc. has 40 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report