Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Lotemax (loteprednol etabonate ophthalmic gel 0.5%) Recalled by Bausch & Lomb Due to Failed Stability Specifications: Out of specification for viscosity.

Date: June 17, 2019
Company: Bausch & Lomb
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 directly.

Affected Products

Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.

Quantity: 170832 bottles

Why Was This Recalled?

Failed Stability Specifications: Out of specification for viscosity.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bausch & Lomb

Bausch & Lomb has 1 total recall tracked by RecallDetector.

Related Recalls

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