The Largest Eye Drop Recall Recorded In Recent US History

Have your eyes ever felt desert-level dry? Maybe itchy? Or sensitive? Your first inclination was probably to fix your issue with rewetting eye drops, which is a standard dry eye treatment option, according to the National Eye Institute. (Just know that dry eyes can signify bigger problems.)

However, you might want to be careful about which brand you're using. Here's why: In 2025, the largest eye drop recall in U.S. history occurred. The recall affected 1.8 million dry eye drop products, many of which had been shipped since 2023 — meaning some bottles were already in the hands of consumers. (Interestingly, the largest deodorant recall was issued in 2025, too.)

The eye drops, distributed by AvKARE, were recalled as part of a U.S. Food and Drug Administration (FDA) Class II event. As noted by FDA Branch Chief Dr. Ileana Elder, Class II recalls are the most commonly seen drug recalls. Class II means that the item in question could lead to medical harm that would be short-term or reversible. She added that staying on top of drug recalls is as easy as visiting the FDA Drug Recall page.

Though it's unclear what adverse effects might come from using the recalled eye drops, AvKARE mentioned that quality-related "deviations" had been found by an FDA audit, leading to the distributor's voluntary recall notice. Five products are named as part of the recall, so you might want to check your home medicine cabinet to see if your dry eye drops are among them. They include Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethylcellulose Sodium Ophthalmic Solution, Lubricant Eye Drops Solution, and Polyvinyl Alcohol Ophthalmic Solution.

What should you do if you have used or unopened bottles of any of the noted AvKARE products? You should first, as a general practice, avoid using any recalled medications. Even if the eye drops appear to be fine and are within their listed expiration dates — and some dates go into 2026 — they have been deemed as unsafe. The company additionally recommends sending back your purchase to receive a refund.

In the past few years, a couple of other eye drop makers have recalled products that are similar to those that were involved in the AvKARE incident. For instance, in 2023, EzriCare eye lubricating drops were pulled from shelves after being linked to serious eye infections and at least one death (via Optometry Advisor). And in 2024, Systane Lubricant Eye Drops Ultra PF were recalled after they were found to contain a fungus (Optometry Advisor).

This isn't the only AvKARE-related recall to make waves in 2025. The distributor, along with another pharmaceutical company, recalled a cholesterol medication after samples failed impurity tests. That said, the recall was on a much smaller scale than the eye drops one, as 10,133 cholesterol drug bottles were involved. It was also listed as a Class III recall, making it less risky from a health perspective for consumers who used the product.