US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Apr 21, 2026 (4 months ago)

Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

What was recalled

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 firm
Alcon Research LLC
NDC code
0065-0474-01
Origin
TX, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0491-2026

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.