FDA Drugs recall ·
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each)… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0200-2025
- Date
- (initiated December 18, 2024)
- Company / brand
- Alcon Research LLC
6201 South Fwy, Fort Worth, TX, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 55,960 25-count boxes
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Why was it recalled?
Non-Sterility
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot 10101; Exp.09/30/2025
Distribution
US Nationwide.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0200-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.