FDA recall D-0492-2026

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.

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2026-04-21

Report date

2026-05-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fort Worth, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0492-2026