Eye drops recalled over fungal concerns: Here's which Systane products are impacted
Select eye drops under the Systane brand were voluntarily recalled for concerns of fungal contamination, which could cause eye infection and threaten users' vision, according to a recall announcement published this week by the Food and Drug Administration.
Alcon Laboratories voluntarily recalled a single lot of Systane Lubricant Eye Drops Ultra PF after it received a consumer complaint regarding foreign material in a sealed single-use vial of the eye drop solution, according to the recall announcement.
The company determined the material was "fungal in nature," the FDA notice reads.
There have been no reports of users having adverse reactions from the contaminated vials.
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How do I know if my eye drops were recalled?
The following product was recalled, according to the FDA:
- Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count: Lot 10101, which expires in September 2025.
The eye drops are used to temporarily relieve "burning and irritation in persons experiencing dry eye symptoms."
They are packaged in a green and pink cardboard box with the brand names Systane” and “ULTRA PF” printed on it, according to the FDA. The solution itself is in 25 plastic vials found in the box.
The product's lot number can be found on the bottom of the box and on the individual vials.
Alcon Laboratories is notifying retailers and people who purchased the product through letters, emails, or phone calls.
Where was the solution distributed?
The solution was distributed nationwide to multiple retail stores and online retailers.
The recalled products were sold at Publix, the chain said in a recall notice dated Dec. 20.
What could happen if the eye drops are used?
The recalled eye drops could cause an eye infection, according to the recall announcement.
An infection caused by the contaminated product could threaten a person's vision and, in rare cases, it could be a life-threatening for users who are immunocompromised.
What should I do with the recalled eye drops?
Immediately stop using the recalled eye drops and return them to the retailer they were purchased from for a replacement or a refund, the FDA notes.
Anyone who has used or purchased eye drops and is suffering from adverse reactions or experiencing quality issues can report them to the FDA's MedWatch Adverse Event Reporting. To report an experience, the FDA offers that people can do one of the following:
- Complete and submit a report online
- Download the form via the link or call 1-800-332-1088 to request a reporting form, then complete and then mail it to return to the address on the pre-addressed form
- Submit the form by fax to 1-800-FDA-0178
Julia is a trending reporter for USA TODAY. You can connect with her on LinkedIn, follow her on X, formerly known as Twitter, Instagram and TikTok: @juliamariegz, or email her at [email protected]