Alcon Research LLC recalls Systane
- Recalling company
- Alcon Research LLC
- Product
- 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
- Reason
- Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 21, 2026
- Reported
- May 6, 2026
- Distribution
- Nationwide within the United States
- Status
- Ongoing
- Lot / codes
- 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.
- Company location
- Fort Worth, TX
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0491-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0491-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.