Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz… recall — Class II (D-0491-2026) · pharmaranks
Class IIOngoing
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Al… recall
FDA recall D-0491-2026 · initiated Apr 21, 2026
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Details
Product
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01
Recalling company
Alcon Research LLC
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide within the United States
Initiated
Apr 21, 2026
FDA report date
May 6, 2026
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.