Class III โ€” Low Risk

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

Atropine Sulfate Ophthalmic 1% Solution Recalled by Akorn, Inc. Due to Failed Stability Specification: OOS low viscosity results discovered...

Date: February 21, 2018
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

Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05

Quantity: 31,812 bottles

Why Was This Recalled?

Failed Stability Specification: OOS low viscosity results discovered during retain testing.

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