Recent recalls, FDA warnings about eye care products are concerning, say experts. Here's how to protect yourself.
A slew of recent recalls and warnings has called into question the safety of products designed to treat and maintain eye health.
On Friday, the Food and Drug Administration warned consumers not to purchase — or if already purchased, to discard — 26 over-the-counter eye care products including eyedrops from CVS, Rite Aid and Target over the "potential risk of eye infections that could result in partial vision loss or blindness." These products are supposed to be sterile, but FDA investigators found unsanitary conditions in the manufacturing facility, along with positive bacterial test results. (The complete list of products can be found here.)
Just last month, the FDA sent warning letters to eight companies for manufacturing or marketing unapproved eye drug products that were in violation of federal law. The products in the letters were “illegally marketed” to treat conditions such as pink eye, cataracts, glaucoma and more, with the FDA noting that some of the companies had quality issues related to the sterility of their products. (Products that aren’t sterile can harbor bacteria and fungi that could lead to eye infections.)
In August, the FDA warned customers not to purchase or use Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops due to the risk of bacterial contamination, fungal contamination or both. The drops contain methylsulfonylmethane (MSM) as an active ingredient, which is an unapproved drug in the U.S. “FDA’s testing showed the products were contaminated with microbes and were not sterile,” the warning says. “Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection.”
There have also been several eye drop recalls this year, with six different products pulled from the market in 2023 alone. One recall, which involved 55 patients in 12 states, was linked to EzriCare Artificial Tears. At least one person died, while others were hospitalized and suffered permanent vision loss due to eye infections from using the products, per the FDA.
With all of that, it’s understandable to feel wary of using over-the-counter eye products. But how worried should you be and how can you stay as safe as possible when using eye drops and similar products? Eye experts break it down.
Do I need to worry?
Eye doctors say the recalls are definitely something to pay attention to. “They’re concerning,” Dr. Vivian Shibayama, an optometrist at UCLA Health, tells Yahoo Life. “But they’re also good because people are reporting them, and the FDA is now alert.”
Dr. Mina Massaro-Giordano, professor of clinical ophthalmology at the University of Pennsylvania, also believes the recalls are serious — and she tells Yahoo Life that they've changed how she advises her patients.
“I’ve told my patients for years to use preservative-free drops because they’re less drying, but now I’m changing my tune,” Massaro-Giordano says. “Preservatives can protect the fluid and decrease your risk of infection.” Massaro-Giordano says she’s also rethinking how she prescribes eye drops to patients. “I’m much more careful of telling patients which drops to get,” she says.
Artificial tears are not required to have FDA approval before going on the market, which can lead to unsafe products being sold, Massaro-Giordano points out.
What can I do about it?
It’s important to consult your doctor, Shibayama says. “If you are suffering from an eye condition, seek advice from your eye care professional instead of trusting the marketing on packages to tell you what you need,” she says. “Be careful with eyedrops purchased on third party online websites like Amazon. You never know what you are getting because some of these online retailers are not regulated.”
Massaro-Giordano also urges her patients to “stick with larger companies and U.S. companies,” although she notes that some American-made drops have been recalled too.
Choosing an eye drop with preservatives may also help, Massaro-Giordano says, given that these products contain ingredients that are designed to tamp down bacterial and fungal growth. If you choose preservative-free drops, she suggests buying single-use drops vs. an entire bottle. That's because the latter option can become contaminated with repeat use and allow bacteria to grow.
The main takeaway
Doctors say the latest recalls and warnings underscore the need to properly vet your eye drops and other eye care products rather than just grabbing what’s on sale or easy to find. “Take your eye health seriously,” Shibayama says.
Massaro-Giordano recommends talking to your eye doctor about which drops are a good choice for you, as well as making sure any new products you’re interested in haven’t been recalled by the FDA. (You can simply search online for the product name and “FDA recall” or “FDA warning.”)
If you're having issues with your eyes, doctors stress the importance of seeking medical care rather than looking for an over-the-counter product. “Consult an eye care professional instead of self medicating,” Shibayama says.
