FDAClass II · Drug · Recalled May 6, 2026

Systane recall — Alcon Research LLC

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0491-2026
Brand: Alcon Research
Classification: Class II
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

Systane

Companies & origin

Recalling firm location: Fort Worth, TX, United States
Firm address: 6201 South Fwy, 76134-2099

Identifying details (verbatim from the notice)

Product codes / lots: Lot#: 9T21, Exp Date: 4/30/2026; Lot# 1U63, 2U47, Exp Date: 5/31/2026; Lot# 6V00, 6V12, 8V54, Exp Date: 1/31/2027; Lot# 9V55, 8V58, 9V39, 9V97, Exp Date: 2/28/2027; Lot# 1W39, 1W40, Exp Date: 3/31/2027; Lot# 1X76, Exp Date: 4/30/2027.
Distribution: Nationwide within the United States
Firm notified the public via: Letter
FDA event ID: 98815
Recall initiated: April 21, 2026
FDA classified: April 24, 2026
FDA report date: May 6, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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