Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Timolol Maleate Ophthalmic Solution Recalled by Akorn, Inc Due to Identification of an unknown impurity at the 12-month...
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
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24
Quantity: 5,226 Cartons (60 vials/carton)
Why Was This Recalled?
Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Akorn, Inc
Akorn, Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report