Alcon Laboratories is voluntarily recalling one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go (25 count), following a consumer complaint regarding the discovery of foreign material inside a sealed vial.
The foreign material was determined to be fungal in nature, prompting the company to act swiftly and recall the affected lot.
The recall, which involves only Lot 10101 with an expiration date of September 2025, affects the Systane Lubricant Eye Drops Ultra PF product, used to relieve dry eye symptoms by temporarily alleviating burning and irritation.
The affected product is packaged in a cardboard carton containing 25 sterile, single-use vials of preservative-free solution.
Fungal contamination in ophthalmic products presents a known risk of eye infections, which may be severe and, in rare cases, potentially life-threatening, particularly for immunocompromised individuals.
Alcon, however, confirmed that it has not received any reports of adverse events linked to the recall at this time.
Consumers who have purchased the affected lot are advised to stop using the eye drops immediately and return the product to the point of purchase for a replacement or a refund.
The product can be identified by its green and pink carton design and the “Systane” and “ULTRA PF” brand names on the packaging.
Alcon is notifying its distributors, retailers, and customers via letters, emails, and phone calls to facilitate the return of all recalled products.
Retailers are also instructed to discard any remaining stock from the affected lot.
For more information, consumers can contact Alcon Laboratories at 1-800-241-5999, Monday through Friday, from 7:30 a.m. to 6:00 p.m. Central Time.
Additionally, any adverse reactions or quality issues related to this product can be reported to the FDA’s MedWatch Adverse Event Reporting Program.
This recall is being conducted with the knowledge and oversight of the U.S. Food and Drug Administration (FDA).