Alcon recalls specific lots of Systane lubricant eye gel due to potential lack of sterility assurance from FDA inspection observations. Consumers should check product details and contact Alcon for remedy.
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Alcon is recalling certain lots of Systane lubricant eye gel that were processed in France. The recall is due to FDA inspection observations that may impact product sterility assurance, though no injuries have been reported.
The FDA observed potential issues with sterility assurance during inspections. This could mean the product is not sterile, which might cause eye infections or irritation if used improperly.
People who own or use the recalled Systane lubricant eye gel products. Those with sensitive eyes or using the product for extended periods may be at slightly higher risk.
Check the product label for the lot numbers: 9T21, 1U63, 2U47, 6V00, 6V12, 8V54, 9V55, 8V58, 9V39, 9V97, 1W39, 1W40, 1X76. The expiration dates range from April 2026 to April 2027.
Look for the lot numbers listed in the recall notice to confirm if your product is affected.
The recall is due to potential lack of sterility assurance from FDA inspections, but no injuries have been reported. Use only if you have the correct lot numbers.
Check the product label for lot numbers: 9T21, 1U63, 2U47, 6V00, 6V12, 8V54, 9V55, 8V58, 9V39, 9V97, 1W39, 1W40, or 1X76.
The recall notice does not specify a remedy, so contact Alcon directly for further instructions.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall D-0491-2026 — Alcon Alcon Hello, I own a Alcon that is covered by recall D-0491-2026 from Alcon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
