FDA Warning: Eye Drops Recalled Nationwide Over ‘Fungal Contamination’

Alcon Laboratories has recalled its Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go eye drops. According to the Food and Drug Administration (FDA), “foreign material” was present inside the single-use bottles, which was later determined to be “fungal in nature.”

Should the substance get into the eyes, it may cause an infection, leading to vision loss or even more life-threatening conditions in immunocompromised patients. So far, Alcon has not reported any infection cases or other adverse events related to the products.

To identify the affected eye drops, consumers should look for a green and pink package with “Systane” and “ULTRA PF” printed on the front. The box holds 25 vials. The affected lot number is 10101, with an expiration date of September 2025.

There is a voluntary recall of Alcon Systane Ultra PF eye drops. Check the lot number on your boxes. https://t.co/IQ9TiDPgi8 pic.twitter.com/boZMvzTLS3

— Florence Eye Center (@florenceeyecntr) December 25, 2024

This particular lot was available nationwide through retail outlets as well as online. Anyone who purchased the eye drops should stop using them immediately. Unused portions or unopened packages can be returned to the place of purchase for a refund or replacement.

Alcon has notified its distributors and retailers of the recall and asked for all contaminated products to be thrown away or destroyed. Alcon will also be delivering replacement eye drop products.

Other Eye Drops and Eye Products Were Recalled

Before the most recent recall of eye drops, four eye ointment products were recalled in February. The over-the-counter eye treatments were removed from store shelves at Walmart and CVS after the FDA suggested the facility where the products originated from may have been unsanitary.  

Two of the recalled products included Equate’s Lubricant Eye Ointment and Stye Lubricant Eye Ointment. The other two were CVS Health Lubricant Eye Ointment and AACE Pharmaceuticals Lubricant PM Ointment. All of them are made by Brassica Pharma in India.

Another recall of eye drops occurred in August 2023. The FDA reported fungal and bacterial contamination in Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops-Eye Repair. Interestingly, both are considered illegal for containing methylsulfonylmethane, or MSM, but were sold online at the time of the recall.

There has certainly been no shortage of recalls lately. Just this week, over 10,000 pounds of raw and prepared pork products were recalled for failure to disclose a possible milk allergy on the packaging.