Systane Lubricant Eye Gel Recalled Due to Sterility Concerns
Alcon Research LLC is recalling Systane Lubricant Eye Gel Night Gel (10g) distributed nationwide due to FDA inspection observations regarding lack of assurance of sterility that may impact product quality.
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: The FDA classified this as a Class II recall. While no illnesses or hospitalizations are reported in the source text, the hazard involves loss of sterility assurance for a sterile ophthalmic drug product, which presents significant risk of adverse health consequences. Class II recalls with quality/safety risks not involving reported illness typically score 4 under the rubric.
Plain-English summary
Alcon Research LLC is recalling Systane Lubricant Eye Gel Night Gel, 10g (0.35 oz), processed in France for Alcon Laboratories, Inc., Fort Worth, TX. The recall affects multiple lot numbers with expiration dates ranging from April 2026 through April 2027. The product was distributed nationwide within the United States.
The recall is due to FDA inspection observations indicating a lack of assurance of sterility that the agency believes may impact product quality. As a sterile ophthalmic product, any compromise in sterility assurance presents a potential safety concern for eye use.
Consumers should stop using affected lots and contact Alcon Research LLC or their healthcare provider with questions. The affected lot numbers are: 9T21 (Exp. 4/30/2026); 1U63, 2U47 (Exp. 5/31/2026); 6V00, 6V12, 8V54 (Exp. 1/31/2027); 9V55, 8V58, 9V39, 9V97 (Exp. 2/28/2027); 1W39, 1W40 (Exp. 3/31/2027); and 1X76 (Exp. 4/30/2027).
The recalled product
- Product
- SYSTANE (HYPROMELLOSE)
- Brand
- SYSTANE
- Manufacturer
- Alcon Research LLC
- Category
- Drug — Ophthalmic / Eye Care
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 (19)
- 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.
UPCs (1)
- 0300650474016
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.
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