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.
What this means for you
Illness, injury, or structural failure has been reported. 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.