FDAClass II · Drug · Recalled May 6, 2026

GenTeal Tears 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-0492-2026
Brand: Alcon Research
Classification: Class II
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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.

Affected products

GenTeal Tears

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 #: 9T20, 9T50, 9T59, 1U30, 1U48, Exp Date: 4/30/2026; 4V15, Exp Date: 8/31/2026; 7V61, Exp Date: 12/31/2026; 1W47, 1W49, 1X14, Exp Date: 3/31/2027.
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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