CLASS II ONGOING Drug recall · Reported 6 May 2026 · FDA Enforcement Report

GenTeal Tears, Lubricant Eye Gel, Sterile recalled by Alcon Research

Alcon Research is recalling GenTeal Tears, Lubricant Eye Gel, Sterile, distributed nationwide in the US. The recall was initiated on 21 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 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.

NDC0065-8064

UPC0300658064011

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0492-2026
FDA event ID: 98815
Recalling firm: Alcon Research, Fort Worth, TX
Brand: Genteal Tears
Manufacturer: Alcon Laboratories, Inc.
Classification: Class II
Status: Ongoing
Recall initiated: 21 Apr 2026
FDA classified: 24 Apr 2026
Reported: 6 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Eye Drops

Timeline

21 Apr 2026	Recall initiated by company
24 Apr 2026	Classified by FDA	+3 days
6 May 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

Nationwide within the United States

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98815

Reported	Class	Recall	Company	Reason	Where
6 May 2026	CLASS II	Systane, Lubricant Eye Gel, Night Gel, Sterile, Processed recalledSystane	Alcon Research	Sterility	Nationwide

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All 107

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Other Hypromellose recalls

All 6

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops All-in-one (hypromellose recalledRohto	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Digi Eye (hypromellose recalledRohto Digi-eye	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
6 May 2026Drug	CLASS II	Systane, Lubricant Eye Gel, Night Gel, Sterile, Processed recalledSystane	Alcon Research	Sterility	Nationwide
4 Mar 2026Drug	CLASS II	Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution recalledVista Gonio Eye Lubricant	Wizcure Pharmaa Private	Sterility	Nationwide
4 Mar 2026Drug	CLASS II	Vista Gel Hypromellose USP 0.3% w/v recalled by Wizcure Pharmaa PrivateVista Hypromellose Dry Eye Relief	Wizcure Pharmaa Private	Sterility	Nationwide