Quick Facts at a Glance
- Recall Date
- April 21, 2026
- Hazard Level
- HIGH
- Brands
- SYSTANE, Alcon Laboratories, Inc.
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- SYSTANE, Alcon Laboratories, Inc.
- Model numbers
- Lot#: 9T21, Exp Date: 4/30/2026, Lot# 1U63, 2U47, Exp Date: 5/31/2026, Lot# 6V00, 6V12, 8V54 +11 more
- UPC codes
- 0065-0474, 0065-0474-01, 0065-0474-02
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 21, 2026
Reported by FDA DRUG
May 6, 2026
RecallRadar source check
May 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Alcon Research LLC or your healthcare provider for guidance. Notification method: Letter
Get instant alerts for SYSTANE recalls
Be the first to know. Free instant alerts to your inbox.
Full 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. Generic: HYPROMELLOSE; Brand: SYSTANE. Reason: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.. Classification: Class II. Distribution: Nationwide within the United States
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
Get instant alerts for recalls that affect you. Free forever.