Drug FDA Class II Ongoing Contamination / non-sterility
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01
Alcon Research LLC Published May 6, 2026
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Alcon Research LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Hazards
Lack of Assurance of Sterility · primary
Affected products (1)
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01
SYSTANE
NDC: 0065-0474, 0065-0474-01, 0065-0474-02
Lot codes: 1U63, 6V00, 9V55, 1W39, 1X76
Code info: 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.
Affected areas
Nationwide
Timeline
- InitiatedApr 21, 2026
- PublishedMay 6, 2026
- Recall number
- D-0491-2026
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.