Why it was recalled
Non-Sterility
Product description
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Lot numbers, UPCs & expiration codes
Lot 10101; Exp.09/30/2025
Where it was sold
US Nationwide.
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-0200-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Dec 18, 2024
- FDA report date
- Jan 22, 2025
- Quantity
- 55,960 25-count boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alcon Research LLC
Original FDA data
Every field from FDA enforcement report D-0200-2025, exactly as published.
Show all FDA fields
- City
- Fort Worth
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 96003
- Address
- 6201 South Fwy
- Code information
- Lot 10101; Exp.09/30/2025
- Postal code
- 76134-2099
- Report date
- Jan 22, 2025
- Product type
- Drugs
- Recall number
- D-0200-2025
- Classification
- Class I
- Recalling firm
- Alcon Research LLC
- Product quantity
- 55,960 25-count boxes
- Reason for recall
- Non-Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Dec 18, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 13, 2025