United StatesSystane Lubricant Eye Gel Night Gel, Sterile, 10 g (NDC 0065-0474-01) and GenTeal Tears Lubricant Eye Gel, Sterile, 10 g (NDC 0065-8064-01) processed/distributed by Alcon are being recalled. The recall is due to lack of assurance of sterility based on FDA inspection observations. The recall covers the specific lots and expiration dates listed by the firm: Lot 9T21 exp 4/30/2026; 9T20, 9T50, 9T59, 1U30, 1U48 exp 4/30/2026; 4V15 exp 8/31/2026; 7V61 exp 12/31/2026; 1U63, 2U47 exp 5/31/2026; 6V00, 6V12, 8V54 exp 1/31/2027; 9V55, 8V58, 9V39, 9V97 exp 2/28/2027; 1W39, 1W40, 1W47, 1W49, 1X14 exp 3/31/2027; 1X76 exp 4/30/2027.
What's being 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
GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.
Recalling firm: Alcon Research LLC, Fort Worth, TX, United States.
How to identify it
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. Lot #: 9T20, 9T50, 9T59, 1U30, 1U48, Exp Date: 4/30/2026; 4V15, Exp Date: 8/31/2026; 7V61, Exp Date: 12/31/2026; 1W47, 1W49, 1X14, Exp Date: 3/31/2027.
The hazard
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the United States
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)