FDA Announces Class I Recall of Systane Lubricant Eye Drops

Alcon Laboratories, Inc., has voluntarily initiated a Class I recall of its Systane Lubricant Eye Drops Ultra PF, a widely used over-the-counter treatment for dry eyes. This recall involves 55 960 boxes containing 25 sterile vials (0.7mL each). The affected product comes from Lot 10101, expiring September 30, 2025, and was distributed across the United States. The recall, initiated on December 18, 2024, was prompted by concerns over non-sterility, which poses a serious risk of infection or injury, especially when used in the sensitive eye area.

Systane Lubricant Eye Drops are designed to temporarily relieve dry eye symptoms by lubricating the ocular surface. The recalling firm, Alcon Research LLC, headquartered in Fort Worth, Texas, issued initial notifications via letters to its consignees and the public. As a Class I recall, this represents the FDA's most serious category, indicating that the use of the product could result in severe health consequences or death.