Agency classClass IIOur severity:Severe FDA (Drugs)·D-0492-2026·Announced 2026-05-06

GenTeal Tears Lubricant Eye Gel Recalled Due to Sterility Concerns

Alcon Research LLC is recalling GenTeal Tears Lubricant Eye Gel nationwide due to FDA inspection observations indicating the product may lack assurance of sterility. Consumers should not use affected lots.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall with a sterility defect in a sterile ophthalmic product that could pose serious health risk if contaminated. Lack of sterility assurance in a product intended for direct eye application meets the Severe threshold for a Class II recall where product quality and safety are compromised.

Plain-English summary

Alcon Research LLC is recalling GenTeal Tears Lubricant Eye Gel, a sterile ophthalmic product, nationwide within the United States. The recall affects specific lots: 9T20, 9T50, 9T59, 1U30, 1U48 (expiring 4/30/2026); 4V15 (expiring 8/31/2026); 7V61 (expiring 12/31/2026); and 1W47, 1W49, 1X14 (expiring 3/31/2027).

The recall was initiated due to FDA inspection observations that the agency believes may impact product quality, specifically regarding lack of assurance of sterility in the recalled product.

Consumers in possession of GenTeal Tears Lubricant Eye Gel with the above lot numbers and expiration dates should stop using the product. The product is distributed by Alcon Laboratories, Inc., Fort Worth, Texas. For additional information or questions, consumers may contact the manufacturer or the FDA.

The recalled product

Product: GENTEAL TEARS (HYPROMELLOSE)
Brand: GENTEAL TEARS
Manufacturer: Alcon Research LLC
Category: Drug — Ophthalmic / Eye Care
Hazard: sterility-defect
contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

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.

UPCs (1)

0300658064011

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Alcon Research LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Alcon Research LLC

See all →

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Critical
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Moderate
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High
Infusion line packs recalled over incomplete seals in sterile pouches
FDA (Devices) · 2025-11-05
High
Vitrectomy probe accessories recalled over incomplete seals in sterile pouches
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Same hazard · sterility defect