Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Atropine Sulfate Ophthalmic Solution Recalled by Akorn, Inc. Due to Failed Stability Specifications: Out of specification test results...
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 Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02
Quantity: 45,117 Bottles
Why Was This Recalled?
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Akorn, Inc.
Akorn, Inc. has 176 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report