Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Xiidra (lifitegrast ophthalmic solution) 5% Recalled by Novartis Pharmaceuticals Corporation Due to Failed Impurities/Degradation Specifications.
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 Novartis Pharmaceuticals Corporation directly.
Affected Products
Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.
Quantity: 1,253,862 vials
Why Was This Recalled?
Failed Impurities/Degradation Specifications.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Novartis Pharmaceuticals Corporation
Novartis Pharmaceuticals Corporation has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report