A couple drops in your eye usually brings relief, not concern—but a rare recall case highlights the importance of a clean, sterile bottle.
Nearly 1.4 Million Over-the-Counter Eye Drops Recalled at FDA’s Highest Risk Level
Published on Jan. 23, 2025
Eye drops may seem an unlikely product to cause severe harm or even death, but an updated announcement from the U.S. Food and Drug Administration (FDA) demonstrates just how hazardous these products can be in cases of contamination. A recent incident involving a brand of eye drops sold at Walmart, on Amazon, and at other mainstream retailers has now been classified under the health authority’s highest risk level.
The Class I recall was first initiated in late December, when the product’s maker, Alcon Laboratories of Fort Worth, TX, which is one of the better-known eye care manufacturers in the country, received a consumer complaint of foreign material sealed within the single-use vials of Systane Lubricant Eye Drops Ultra PF.
The company determined the contamination to be fungal, and announced that 55,960 25-count boxes of the eye drops were unfit for usage due to non-sterility. In total, the recall is said to affect 1,399,000 eye drop vials, which were distributed nationwide across a range of major retailers.
The affected products were sold in green and pink boxes and marketed as an “on-the-go” treatment for dry, itchy, and irritated eyes. Consumers can identify the affected products using the following information:
- Lot Number: 10101
- Exp. Date: September 2025
A company announcement on the FDA site helps explain why this eye drop quality issue could be serious. “Fungal contamination of an ophthalmic product is known to potentially cause eye infections. If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients.” At the time of that announcement, Alcon Laboratories reported they had not received any reports of adverse events linked to the recall.
In a separate brief, the FDA explains why consumers should understand why eye care safety is so important: “Ophthalmic drug products, such as eye drops, pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. Any drug used in the eyes must be sterile to reduce the risk of infection.”
The administration adds that there have been multiple incidents involving over-the-counter eye drop products in recent years, including seven major recalls since 2023. “These recalls resulted from various safety concerns, including reports of infections, partial loss of vision, and blindness. The recalls were due to product contamination risks,” they note.
If you have purchased the contaminated eye drops, one avenue of remedy may be to try returning them to your place of purchase for a replacement or refund. Consumers with questions regarding this recall can contact Alcon Laboratories. You may also consider reporting any adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Inquire with a credentialed healthcare professional if you have used the recalled lot.
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