Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Bromfenac Ophthalmic Solution 0.09% Recalled by Apotex Inc. Due to CGMP Deviations: Product excipient was not re-tested at...
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%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4.
Quantity: 33,795 Bottles
Why Was This Recalled?
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
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