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.

Bromfenac Ophthalmic Solution Recalled by Bausch & Lomb, Inc. Due to Lack of Assurance of Sterility: Failed preservative effectiveness...

Date: August 17, 2015
Company: Bausch & Lomb, Inc.
Status: Terminated
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 Bausch & Lomb, Inc. directly.

Affected Products

Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.

Quantity: 13,995 Bottles

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.

Affected (51 states)Not affected

About Bausch & Lomb, Inc.

Bausch & Lomb, Inc. has 9 total recalls tracked by RecallDetector.

Related Recalls

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