Systane Gel
FDA Recall NDC 0065-0474
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Systane (NDC 0065-0474). A significant event, classified as Class II, was initiated on Apr 21, 2026 by Alcon Laboratories, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Apr 21, 2026
May 06, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98815
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Alcon Research LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
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
Batch or Lot Expiration Information
Lot# : 9T21, Exp Date: 4/30/2026
Lot# 1U63, 2U47, Exp Date: 5/31/2026
Lot# 6V00, 6V12, 8V54, Exp Date: 1/31/2027
Lot# 9V55, 8V58, 9V39, 9V97, Exp Date: 2/28/2027
Lot# 1W39, 1W40, Exp Date: 3/31/2027
Lot# 1X76, Exp Date: 4/30/2027.
Affected Packages Involved in this Recall
0065-0474-01Product
0065-0474-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
