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.

Recall Number: D-0492-2026

Firm: Alcon Research LLC

Classification: Class II

Status: Ongoing

Report Date: 20260506

Initiation Date: 20260421

Termination Date:

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

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.