Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Phenylephrine Hydrochloride Ophthalmic Solution Recalled by Akorn, Inc. Due to Lack of Assurance of Sterility: Out of specification...
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
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
Quantity: 60,176 bottles
Why Was This Recalled?
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
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