Class III โ€” Low Risk

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

Proparacaine Hydrochloride Ophthalmic Solution Recalled by Akorn, Inc. Due to Chemical contamination; out of specification results obtained for...

Date: December 26, 2019
Company: Akorn, 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 Akorn, Inc. directly.

Affected Products

Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12

Quantity: 33,343 bottles

Why Was This Recalled?

Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Akorn, Inc.

Akorn, Inc. has 176 total recalls tracked by RecallDetector.

Related Recalls

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