Class III โ€” Low Risk

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

Tropicamide Ophthalmic Solution USP Recalled by Bausch & Lomb, Inc. Due to Labeling: Incorrect or Missing Package Insert: Package insert...

Date: January 18, 2016
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

Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.

Quantity: 119,393 Bottles

Why Was This Recalled?

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

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