Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort W
Summary
The FDA issued a Class II for Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in Fran by Alcon Research LLC. Reason: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality..
Details
Source
Drug Recall
External ID
D-0491-2026
Action Date
2026-05-06
Status
Ongoing
Category
drug
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
Lot/Code Info: 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.
Reason for Recall
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-21
Company
Fort Worth, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 65 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Alcon Research LLC has 66 FDA actions in our database, including 66 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Alcon Research LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Alcon Research LLC have FDA actions?
Alcon Research LLC has 66 FDA actions in our database, including 66 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0491-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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