Alcon GenTeal Tears Eye Gel Recall: Lack of Sterility Assurance
Alcon recalls sterile GenTeal Tears eye gel due to potential lack of sterility. Products distributed by Alcon Laboratories with specific lot numbers and expiration dates are affected. Consumers should check their product details and contact Alcon for guidance.
Lower-risk recall
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Contact the company
What happened, in plain English
Alcon is recalling sterile eye gel products called GenTeal Tears because of concerns about possible lack of sterility. This could lead to infections if the product is not properly sterile. The recall affects specific lot numbers and expiration dates. Read more at govinfonow.com/recall/31341-alcon-genteal-tears-eye-gel-recall-lack-of-sterility-assurance.
Source Summary by GovInfoNow · govinfonow.com/recall/31341-alcon-genteal-tears-eye-gel-recall-lack-of-sterility-assurance · Updated August 17, 2026 · FDA enforcement record: FDA #D-0492-2026
Cite this page
“Alcon GenTeal Tears Eye Gel Recall: Lack of Sterility Assurance.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31341-alcon-genteal-tears-eye-gel-recall-lack-of-sterility-assurance. Based on FDA recall #D-0492-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0492-2026%22&limit=1).
Why it’s dangerous
The product may not be sterile due to FDA inspection observations that could impact quality. If the eye gel is not sterile, it could cause eye infections or irritation when used.
Who’s affected
People who own or use GenTeal Tears eye gel with the specific lot numbers and expiration dates listed in the recall notice. Those with sensitive eyes or compromised immune systems may be at slightly higher risk.
How to tell if you have this one
Check the product label for the lot numbers: 9T20, 9T50, 9T59, 1U30, 1U48, 7V61, 1W47, 1W49, 1X14. Also look for the expiration dates: 4/30/2026, 8/31/2026, 12/31/2026, or 3/31/2027.
- Brand
Alcon- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide within the United States
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0491-2026 | 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#: 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. | — | 0065-0474-01, 0065-0474-02 |
| D-0492-2026 | 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.; 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. | — | 0065-8064-01 |
What to do — step by step
Check Product Details
Look for the lot numbers and expiration dates on the product label to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 15 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0492-2026 (April 21, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0492-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.