A pharmaceutical company is voluntarily recalling more than three million bottles of eye drops. The company made the move after the U.S. Food and Drug Administration (FDA) issued an Enforcement Report that cited a "lack of assurance of sterility."
The affected batches are sold under numerous brand names and distributed to retailers including Walgreens, Kroger and CVS. Some of the brands include: "Ultra Lubricating Eye Drops," "Dry Eye Relief Eye Drops," "Sterile Eye Drops," and "Artificial Tears Sterile Lubricant Eye."
For a full list, including lot numbers and expiration dates, see below or check the FDA's enforcement report. Consumers are advised to discard the recalled bottles.
OTC eye drops do not require prior FDA review
This current eye-drop recall follows several such recalls over the past few years, during which products were taken off the shelves due to the risk of serious infections. In 2023, recalled eye drops were associated with four deaths, 14 cases of vision loss and 80 infections. The source of the infections was a drug-resistant bacterium, Pseudomonas aeruginosa.
Gary Novack is a clinical professor in the UC Davis Department of Ophthalmology and Vision Science. He is a board-certified clinical pharmacologist and a consultant in ophthalmic product development.
Details about why these eye drops were recalled have not been released.
But Novack notes that, unlike prescription eye drops — such as those used to treat glaucoma, dry eyes or retinal diseases — over-the-counter eye products do not require prior FDA review before they are sold.
"That said, they still need to be compliant with what is known as Current Good Manufacturing Practice. For eye drops, that means strict sterility, ensuring products are free from microorganisms like bacteria," Novack said.
Inspections can reveal problems
Although they don't require prior review, FDA inspections of manufacturing facilities making over-the-counter eye products may occur at any time. This can highlight previously unknown problems in the manufacturing process or facility, according to Novack.
He notes that all medications used in the eye must be stable (meaning the composition of the drops does not change before the expiration date) and sterile (free of germs).
"To achieve that, manufacturing sites must be free of microbes, and products must be designed to prevent contamination," Novack said.
Infections from eye drops are uncommon
Eye infections from eye drops can be serious but are, luckily, very uncommon. The current voluntary recall has not reported any infections to date.
Jeffrey H. Ma, an ophthalmologist at the UC Davis Eye Center, specializes in diseases that damage the surface layers of the eye.
For his patients with dry eyes, he routinely recommends preservative-free drops that come in disposable single-use vials.
"Drops that are not on the recall list should be safe to use," Ma said, "If you have any of the drops on the list, you should immediately throw them away."
How to avoid common eye infections
Although contaminated eye drops grab headlines when it comes to eye infections, he notes people get common eye infections in much more ordinary ways.
"Conjunctivitis, known as pink eye, is the most common type of eye infection," he said. Pink eye is estimated to affect about six million people every year.
"It is usually viral or bacterial, and is transmitted through direct contact, such as touching or rubbing your eyes after touching a contaminated item," Ma said.
Bacterial conjunctivitis is treated with antibiotic drops, but viral conjunctivitis can clear up on its own.
Because conjunctivitis is easy to spread, people who are near someone with pink eye are also at risk of getting an eye infection. Ma suggests being diligent about washing hands frequently, especially before touching your face or eyes.
Contact lens wearers have a higher risk of eye infections, particularly if they sleep in their lenses. Proper hygiene — washing hands before touching the lenses — can help prevent eye infections. Although less common, infections can also occur when dormant viruses, such as those that cause herpes or shingles, reactivate in the eye.
Symptoms of an eye infection include:
- blurry vision
- discharge
- pain or discomfort
- redness of the eyelid or eye
- feeling like there is something in the eye
- increased sensitivity to light
"If you have any of these symptoms and they are not improving or getting worse, please make an appointment to see an eye care professional," Ma said.
Recalled eye drops
Below is the FDA list of the over-the-counter eye drops recalled as of April 2026. Check the FDA's enforcement report for any updates.
