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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Over-the-Counter

Systane Ultra PF Lubricant Eye Drops Recalled for Non-Sterility

Agency Publication Date: January 13, 2025
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Summary

Alcon Research LLC is recalling 55,960 25-count boxes of Systane Lubricant Eye Drops (Ultra PF) because the product may not be sterile. Using non-sterile eye drops can lead to serious infections or other complications. The affected boxes contain 25 single-use vials and are marked with lot number 10101 and an expiration date of September 30, 2025.

Risk

Non-sterile eye drops can introduce bacteria or other contaminants directly into the eye. This poses a critical risk of serious eye infections that can result in permanent damage to vision or vision loss.

What You Should Do

  1. This recall affects Systane Lubricant Eye Drops, Ultra PF, sold in boxes containing 25 single-use vials (0.7mL Each).
  2. Check the side or bottom of your box and the individual vials for lot number 10101 and expiration date 09/30/2025.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.

Your Remedy Options

You have 2 options:

💰Option 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
🗑️Option 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Systane Lubricant Eye Drops, Ultra PF (25 Vials, 0.7mL Each)
Variants: Preservative-Free, 25-count box
Lot Numbers:
10101 (Exp. 09/30/2025)

Quantity: 55,960 25-count boxes

Product Images

Image 1: “Front Panel of Carton, Systane Lubricant Eye Drops, 25 vials, 0.7 mL each”

Image 1: “Front Panel of Carton, Systane Lubricant Eye Drops, 25 vials, 0.7 mL each”

Image 2: “Bottom Panel of Carton with lot code and expiration date”

Image 2: “Bottom Panel of Carton with lot code and expiration date”

Image 3: “Photograph of vials with lot code and expiration date”

Image 3: “Photograph of vials with lot code and expiration date”

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96003
Status: Active
Manufacturer: Alcon Research LLC
Sold By: Retail pharmacies; Drug stores
Manufactured In: United States
Units Affected: 55,960 25-count boxes
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.