FDA recall, , Moderate risk
GenTeal Tears and Systane Lubricant Eye Gel
Systane Lubricant Eye Gel Night Gel may lack assurance of sterility.
Summary by Recall Canary from the FDA notice
What happened
Alcon Research LLC of Fort Worth, Texas, recalled GenTeal Tears Lubricant Eye Gel and Systane Lubricant Eye Gel Night Gel due to a lack of assurance of sterility, based on FDA inspection observations that may impact product quality. The recall began on April 21, 2026, and was added to the FDA's Enforcement Report on April 24, 2026. The products were distributed nationwide within the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
2 products
Match the lot code and NDC listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz)
- NDC
- 0065-8064-01
- Lot code
- 9T20
- 9T50
- 9T59
- 1U30
- 1U48
- 4V15
- 7V61
- 1W47
- 1W49
- 1X14
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 code
- 9T21
- 1U63
- 2U47
- 6V00
- 6V12
- 8V54
- 9V55
- 8V58
- 9V39
- 9V97
- 1W39
- 1W40
- 1X76
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- Alcon Research LLCFort Worth, Texas
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98815
- Recall numbers
- D-0491-2026 to D-0492-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
