Over 27 Eye Drops Have Been Recalled: What You Need to Know
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It’s been a bad year for eye drops. The U.S. Food and Drug Administration (FDA) has issued yet another eye drop recall—this time focusing on 27 different over-the-counter products over concerns about the potential risk of eye infections that could lead to partial vision loss or blindness.
The FDA says the eye drops are marketed under retailers and brands Walmart, CVS Health, Rite Aid, Target Up&Up, Leader, Rugby, and Velocity Pharma, and are “intended to be sterile.” (You can see the full list of recalled drops on the FDA’s website.)
According to the recall notice, FDA investigators found “unsanitary conditions” in the manufacturing facility of the eye drops and received positive bacterial test results from drug production areas in the facility. While CVS, Rite Aid, and Target are removing the eye drops from their stores and websites, the FDA says that Leader, Rugby, and Velocity may still be available to buy in stores and online, but shouldn’t be purchased or used.
If you have any of these eye drops at home, the FDA recommends getting rid of them. If you’ve already used them and develop signs of an eye infection, the agency says it’s important to talk to your healthcare provider or seek medical care “immediately.”
This is hardly the first warning or recall of eye drops this year. So, what’s going on, and which drops have been impacted? Here’s what you need to know, plus signs of an eye infection to look out for.
What’s going on with eye drop recalls?
If eye drop recalls seem popular right now—it’s not just your imagination. In general, eye drops have been recalled over the past year due to either contamination or a lack of sterility. Both are major issues, Aaron Zimmerman, O.D., a clinical professor at The Ohio State University College of Optometry says.
In August, the FDA issued a warning to the public not to purchase, or to immediately stop using, Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops—Eye Repair due to a risk of bacterial contamination, fungal contamination, or both.
The FDA also said that the drops contained the ingredient methylsulfonylmethane (MSM), which is not approved for use in eye-related products in the U.S.
In May, the Centers for Disease Control and Prevention (CDC) noted 81 patients in 18 states with VIM-GES-CRPA, a rare strain of the drug-resistant Pseudomonas aeruginosa. Certain types of artificial tears have been named as a common exposure for many patients. So far, 14 patients have gone blind and an additional four had to have their eyeballs surgically removed.
Despite these disturbing numbers, doctors stress that eye drop recalls have not been common in the past, and they’re incredibly rare in known brand names. “The vast majority of products available on the shelves in the United States are cleared by the FDA and subject to investigations if there is a safety issue with a product,” says Zimmerman.
Still, issues can come up with sterility. “This is a bit concerning,” says Mina Massaro-Gordon, M.D., a professor of clinical ophthalmology at the University of Pennsylvania.
Nandini Venkateswaran, M.D., an ophthalmologist and member of the Cornea and Refractive Surgery Service at Mass Eye and Ear, agrees. “Eye infections can affect not only the front of the eye but also the inside of the eye and can cause vision loss,” she says.
What eye drops should I avoid?
While this seems like a lot (and it is), Zimmerman says consumers should generally feel safe purchasing artificial tears from known brands. “Up until this year, I don’t recall ever hearing of an artificial tear recall in my career,” he says. “The majority of the products available on the shelves in stores are safe and the companies that manufacture them follow very stringent manufacturing processes.”
Still, Dr. Massaro-Gordon says all of these recalls should cause people to be extra aware of what they’re purchasing. “Patients and doctors have to do their research to make sure eye drops they’re considering aren’t on the FDA’s list,” she says.
Another pro tip, per Vivian Shibayama, O.D., an optometrist at UCLA Health: “Don’t touch [the] dropper to the eye.” This raises the risk you’ll contaminate your drops. And, if you’ve purchased single-use drops, she recommends actually following the instructions and tossing leftover drops after each use.
It’s also a good idea to check in with your doctor if you’re unsure of a brand, Dr. Venkateswaran says. “I tell patients to look at a list that I provide them of the most commercially available artificial tear drops that we recommend and vet,” she says. “There are drops with and without preservatives. It’s just important to purchase the brands we know and trust.”
Zimmerman agrees. “Don’t always purchase the least-expensive product and if you are finding that you can only find the product online or from another non-traditional vendor, or is not available in the United States, then pause and question whether you should be purchasing that product,” he says.
List of eye drops recalled so far in 2023
It can be hard to keep track of all the eye drops that have been recalled this year. Here’s a full list:
Why are these eye drops being recalled?
Kilitch Healthcare India Limited
Kilitch Healthcare India Limited is voluntarily recalling eye drops under multiple brand names (including Walmart, Rite Aid, CVS Health, Rugby, Leader, and Target), with expiration dates from November 2023 through September 2025 after the FDA noted potential safety concerns due to insanitary conditions.
CVS Health
FDA investigators detected issues with sterility in manufacturing these drops. Some production areas also contained bacteria.
Rugby (Cardinal Health)
Rugby’s eye drops were listed as part of the recall alongside CVS. Meaning, there were concerns about sterility and bacterial contamination.
Leader (Cardinal Health)
Leader’s drops were included in the October recall over concerns about sterility and bacterial contamination.
Rite Aid
Rite Aids eye drops were recalled over concerns about sterility and bacterial contamination.
Target Up&Up
Target’s Up&Up brand’s eye drops were recalled in October over sterility and bacteria concerns.
Velocity Pharma LLC
Velocity Pharma had one type of eye drop included in the October recall. It was recalled over fears of lack of sterility and bacterial contamination.
Dr. Berne’s
The FDA issued a warning to consumers, noting that testing determined that the drops were not sterile and contained microbes. They also contained methylsulfonylmethane (MSM) as an active ingredient, which is unapproved for use in the U.S.
LightEyez
LightEyez contains MSM and has drops that aren’t sterile, per the FDA.
EzriCare
These drops were linked to a multistate outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa, per the CDC.
Delsam Pharma
As a part of the same recall as EzriCare artificial tears, these drops were linked to a multistate outbreak of Pseudomonas aeruginosa, per the CDC. “The outbreak is associated with multiple types of infections, including eye infections,” the CDC noted in its initial warning.
Purely Soothing
These drops were recalled after two lots were found to not be sterile. No illnesses have been tied to the recall so far. These codes were part of the recall:
Clear Eyes Once Daily
Teva Pharmaceuticals recalled select batches of the eye drop after they failed an impurities test. More than 700,000 bottles were recalled.
Brimonidine
These eye drops, which are intended to be used by people with glaucoma or ocular hypertension, had faulty caps that could lead to unsterile solutions, the FDA noted.
What are the symptoms of eye infection?
Many of the infections linked to eye drops are of the cornea, Zimmerman says. He says to look out for the following symptoms:
Significant pain
Significant light sensitivity
Blurred vision
Red eyes
Watery-mucus discharge
Swelling around the eye
There are several types of eye infections, though. The most common type is conjunctivitis (a.k.a. pink eye), the Cleveland Clinic explains. Symptoms can include:
Red eyes
Itching or irritation
Eye pain
Watery eyes
Swelling
If you have symptoms of an eye infection, Zimmerman says it’s important to seek care from an optometrist or ophthalmologist. “These individuals are trained and deal with eye infections regularly,” he says. “They can differentiate between viral, bacterial, and other infectious microbes and then treat them appropriately.”
How to treat an eye infection
First and foremost, if you have been using any of the recalled products and think you may have an eye infection, speak with your healthcare provider ASAP. Next, if you suspect that you have an eye infection and wear contacts, it’s important to remove them and switch back to glasses, says Vivian Shibayama, O.D., an optometrist at UCLA Health. Treatment really depends on the cause of the infection, the Cleveland Clinic says, but may include:
Damp, warm, or cool compresses
Artificial tears
Over-the-counter pain relievers
Antibiotics (for bacterial infections)
“If it is bacterial, such as the infections associated with the recalls, then a broad spectrum antibiotic eye drop is prescribed,” Zimmerman says. “The patient will instill drops hourly—sometimes even more often than that—until the ocular surface begins to improve. The patient will then be followed regularly until the infection has resolved.”
The biggest concern is about post-infection corneal scarring, Zimmerman says. “This scarring can substantially impair vision and may result in a corneal transplant,” he points out. “If identified early and proper treatment occurs, then the risk of post-infectious scarring is much lower than if it were delayed.”
This is a developing reported story. All information is accurate as of press time.
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