Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gentamicin Sulfate Ophthalmic Solution Recalled by Akorn, Inc. Due to Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for...
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
Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.
Quantity: 51,456 bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.
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