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Drug FDA Class I Ongoing Contamination / non-sterility

Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134

Alcon Research LLC Published Jan 22, 2025

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Alcon Research LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Non-Sterility

Hazards

Non-Sterility · primary

Affected products (1)

Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134

55,960 25-count boxes

Lot codes: 10101
Code info: Lot 10101; Exp.09/30/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Dec 18, 2024
  2. Published
    Jan 22, 2025
Recall number
D-0200-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.