“Alcon Systane Lubricant Eye Drops Recall: Non-Sterility Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32355-alcon-systane-lubricant-eye-drops-recall-non-sterility-hazard. Based on FDA recall #D-0200-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0200-2025%22&limit=1).
Alcon Research LLC recalled Systane Lubricant Eye Drops, Ultra PF, Sterile due to non-sterility hazards, the FDA said on December 18, 2024. The voluntary Class I recall affects 55,960 units distributed nationwide.
The recall is due to non-sterility of the Systane Lubricant Eye Drops. The FDA classified this as a Class I recall, indicating a reasonable probability that the product could cause serious adverse health consequences or death.
Context
GovInfoNow's records show Alcon Research LLC has issued 24 other recalls since July 25, 2018. Recent similar recalls include an April 21, 2026 recall of Alcon GenTeal Tears Eye Gel for lack of sterility assurance and a November 24, 2025 recall of Alcon Custom Pak due to incomplete seals. Other recent recalls of similar products include K.C. Pharmaceuticals Ultra Lubricating Eye Drops (March 3, 2026), K.C. Pharmaceuticals Sterile Eye Drops AC (March 3, 2026), and TRP Gentle Eyes Lubricant Eye Drops (August 20, 2026).
How to tell if you have this one
Check for the product name 'Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 vials (0.7mL each)'. Look for lot number 10101 and expiration date 09/30/2025.
Brand
Alcon
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the lot number 10101 and expiration date 09/30/2025 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0200-2025 (December 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0200-2025 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.