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 for recall: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Recall initiated: 20260421
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated