FDAFDA · Food and drugs·Recall number D-0491-2026
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
Published May 6, 2026 · Recall initiated: April 21, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SYSTANE
- Manufacturer
- Alcon Research LLC
- Distributor
- Nationwide within the United States
- UPC
- 0300650474016
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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