Systane Lubricant Eye Drops recall
FDA recall D-0200-2025 · initiated Dec 18, 2024
Alcon Research LLC recalled Systane Lubricant Eye Drops in Dec 2024 — an FDA Class I recall (D-0200-2025) because Non-Sterility.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Non-Sterility
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 55,960 25-count boxes
Details
- Product
- Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
- Recalling company
- Alcon Research LLC
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Dec 18, 2024
- FDA report date
- Jan 22, 2025
Frequently asked
- Was Systane Lubricant Eye Drops recalled?
- Alcon Research LLC recalled Systane Lubricant Eye Drops in Dec 2024 — an FDA Class I recall (D-0200-2025) because Non-Sterility. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Systane Lubricant Eye Drops recalled?
- Per the FDA enforcement record, the reason for recall D-0200-2025 was: Non-Sterility
- Is a recalled Systane Lubricant Eye Drops dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Systane Lubricant Eye Drops are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot 10101; Exp.09/30/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0200-2025.