FDA recall D-0491-2026

Product

Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01

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-0491-2026