Systane Eye Gel Recall Due to Sterility Concerns
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Alcon Laboratories is recalling certain lots of Systane Lubricant Eye Gel due to a lack of assurance of sterility, affecting products distributed nationwide in the United States.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, drugs.
What Happened
Alcon Research LLC is recalling Systane Lubricant Eye Gel because of a lack of assurance of sterility, stemming from FDA inspection observations that may impact product quality.
Which Products Are Affected
The affected product is Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), with NDC 0065-0474, package NDCs 0065-0474-01 and 0065-0474-02, and UPC 0300650474016. The recall includes the following lots: 9T21 with expiration date 4/30/2026; 1U63 and 2U47 with expiration date 5/31/2026; 6V00, 6V12, and 8V54 with expiration date 1/31/2027; 9V55, 8V58, 9V39, and 9V97 with expiration date 2/28/2027; 1W39 and 1W40 with expiration date 3/31/2027; and 1X76 with expiration date 4/30/2027. The product was distributed nationwide within the United States, and the recall number is D-0491-2026.
What You Should Do
Consumers who have the affected lots should follow the initial firm notification, which was issued via letter, and contact the recalling firm, Alcon Research LLC at their address: 6201 South Fwy, Fort Worth, TX 76134-2099, for further instructions on returns or refunds.
Why This Matters
This recall highlights potential risks associated with eye care products that may not meet sterility standards, affecting consumer safety nationwide.
Source
FDA recall notice: D-0491-2026, attributed to the FDA database.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,360 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.