Alcon Recalls TEARS Naturale FREE Eye Drops Due to Sterility Risk
Alcon recalls specific lots of TEARS Naturale FREE eye drops because some vials may contain water instead of the solution, posing a sterility risk.
Stop using this now
Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.
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What happened, in plain English
Alcon Research, Ltd. is recalling TEARS Naturale FREE lubricant eye drops because some single-use vials may have been filled with water rather than the intended product solution. The company cannot guarantee that these specific vials are sterile, which poses a health risk to users. This recall affects 12,648 cartons distributed nationwide. Read more at govinfonow.com/recall/43165-alcon-recalls-tears-naturale-free-eye-drops-due-to-sterility.
Source Summary by GovInfoNow · govinfonow.com/recall/43165-alcon-recalls-tears-naturale-free-eye-drops-due-to-sterility · Updated October 11, 2026 · FDA enforcement record: FDA #D-0666-2016
Cite this page
“Alcon Recalls TEARS Naturale FREE Eye Drops Due to Sterility Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43165-alcon-recalls-tears-naturale-free-eye-drops-due-to-sterility. Based on FDA recall #D-0666-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0666-2016%22&limit=1).
Why it’s dangerous
The primary hazard is a lack of assurance of sterility. If a vial contains water instead of the lubricant solution, it may introduce pathogens to the eye, potentially causing serious infection or injury since the sterility cannot be guaranteed.
Who’s affected
Consumers who purchased TEARS Naturale FREE lubricant eye drops in single-use vials between the manufacture date and expiration date of September 17. Users of this specific preservative-free formula are at risk if they possess the affected lot.
How to tell if you have this one
Check your product for the brand name TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL. Look for Lot # KRJ006 and an expiration date of 09/17. The packaging includes a barcode 90016741106 and UPC 3 00650 41636 8.
- Brand
Alcon- Product
TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL- Category
Drug
What to do — step by step
Stop using the product
Do not use any eye drops from Lot # KRJ006 with expiration date 09/17 due to potential sterility issues.
Check your lot number
Verify if your package matches Lot # KRJ006 and UPC 3 00650 41636 8 to determine if it is part of this recall.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have the recalled item?
The record states a remedy is not currently provided (null), so you should stop using the product immediately and contact Alcon for further instructions.
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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-0666-2016 (February 9, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0666-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.