FDA Warns of Massive Eye Drop Recall Due to Fungal Contamination

I use eye drops pretty much every morning. Sometimes, my family picks up a different brand if there is a sale or if our regular ones are out of stock.

Alcon Laboratories Issues Voluntary Recall

The FDA has announced a major recall of one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count due to potential fungal contamination. Alcon Laboratories initiated the recall after a consumer complaint revealed fungal material inside a sealed single-use vial.

Why This Matters: Risk of Eye Infections

Fungal contamination in eye products can lead to serious complications, including vision-threatening infections. While no adverse events have been reported so far, the FDA warns that such infections could pose severe risks, especially for immunocompromised individuals.

Affected Product Details

The recall specifically applies to:

• Lot Number: 10101
• Expiration Date: 2025/09
• Packaging: Green and pink carton labeled “Systane” and “ULTRA PF” with 25 single-use vials
• Distribution: Nationwide via retail and online outlets

Consumers should stop using the product immediately and return it to the purchase location for a refund or replacement.

What to Do If You Have This Product

If you have the recalled eye drops, follow these steps:

1. Stop Use Immediately: Do not use the product to avoid potential risks.
2. Return or Replace: Bring the product back to the store or contact Alcon Laboratories at 1-800-241-5999 (Monday–Friday, 7:30 a.m.–6:00 p.m. Central).
3. Seek Medical Advice: Contact a healthcare provider if you’ve experienced any unusual symptoms.

Reporting Adverse Reactions

Consumers who encounter issues with this product are encouraged to report them to the FDA through the MedWatch Adverse Event Reporting Program:

• Online: FDA MedWatch
• Phone: 1-800-332-1088

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration to ensure public safety. Stay informed and take precautions to protect your health.

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