Why it was recalled
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Product description
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
Lot numbers, UPCs & expiration 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.
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0491-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 21, 2026
- FDA report date
- May 6, 2026
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alcon Research LLC
Original FDA data
Every field from FDA enforcement report D-0491-2026, exactly as published.
Show all FDA fields
- City
- Fort Worth
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 98815
- Address
- 6201 South Fwy
- Code information
- 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.
- Postal code
- 76134-2099
- Report date
- May 6, 2026
- Product type
- Drugs
- Recall number
- D-0491-2026
- Classification
- Class II
- Recalling firm
- Alcon Research LLC
- Reason for recall
- Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Apr 21, 2026
- Initial firm notification
- Letter
- Center classification date
- Apr 24, 2026