Alcon Research LLC drug recall: Systane Lubricant Eye Drops
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96003
- Recall initiated
- Dec 18, 2024
- Classified by FDA
- Jan 13, 2025
- Posted in Enforcement Report
- Jan 22, 2025
- Recalling firm
- Alcon Research LLC
- Firm location
- Fort Worth, TX, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Non-Sterility
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Dec 18, 2024. FDA classified it 26 days later, on Jan 13, 2025. Distribution reported by FDA: US Nationwide. Alcon Research LLC has 53 recalls in our records.
Recalled products (1)
D-0200-2025 Class I Ongoing
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Codes / lots: Lot 10101; Exp.09/30/2025
Quantity: 55,960 25-count boxes
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 96003
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.