Alcon Research Llc: Systane, Lubricant Eye Gel, Night Gel, Sterile
Recall Summary Alcon is recalling Systane Lubricant Eye Gel Night Gel (10g tubes) distributed nationwide because the company cannot guarantee the product is sterile due to FDA inspection findings. The recall affects the product with NDC number 0065-0474-01 that was processed in France for Alcon Laboratories in Fort Worth, Texas.
- Recalling firm
- Alcon Research LLC
- Product
- 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
- Reason
- Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-21
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the United States
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/b13dbda4-45ca-4aa6-bd1e-a1f300e91b29