Alcon Research Llc: Genteal Tears, Lubricant Eye Gel, Sterile
GenTeal Tears Lubricant Eye Gel Recall Summary Alcon is recalling GenTeal Tears Lubricant Eye Gel (10g tubes, NDC 0065-8064-01) nationwide due to concerns that the product may not be sterile. The FDA found manufacturing issues during an inspection that raised questions about whether the product meets sterility standards. This is a Class II recall affecting consumers across all 50 states and Washington, D.C.
- Recalling firm
- Alcon Research LLC
- Product
- GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.
- 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/25c513fb-dc31-4a74-9c34-b713449210b8