Alcon Research Llc: Genteal Tears, Lubricant Eye Gel, Sterile
Recall Summary Alcon is recalling GenTeal Tears Lubricant Eye Gel (10g bottles) nationwide because the FDA found issues during an inspection that may affect whether the product is properly sterilized. The product was distributed across all U.S. states and is identified by NDC number 0065-8064-01.
- 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/2a5b5326-f921-44b0-bb92-6f8e3f8b407b