Dozens of eye drops and ointments have been pulled from store shelves after a wave of recalls in 2023 and 2024, raising concerns about whether products used to relieve dry or irritated eyes are safe.
Most recently, the drug company Brassica Pharma recalled four eye ointments sold in stores, including Walmart and CVS, after a Food and Drug Administration inspection flagged potential sterility issues. There have been no reports of health problems linked to the ointments.
Although recent warnings may seem unsettling, the recalls are evidence that health safety systems are working, said Tim Corson, a professor at the University of Toronto who specializes in developing new drugs for eye diseases.
Why are so many eye products being recalled?
The recalls have largely involved over-the-counter eye drops and ointments, including “copycat” eye drops, which are designed to look like common brands but haven’t been approved by the F.D.A. and sometimes carry misleading health claims.
Eye-care products have a higher risk of health harm because they’re applied directly to the eye, which means they can bypass some of the body’s natural defenses against contaminants. And manufacturing and storing them in a way that is sterile is also difficult, explained Gary Novack, a clinical professor of ophthalmology and vision science at the UC Davis School of Medicine and president of PharmaLogic, which consults companies on drug development. For example, eye drops contain sodium chloride, or salt, and some “bugs like to grow in salty water,” Dr. Novack said
These challenges can cause problems that lead manufacturers to pull a product from shelves. But Dr. Corson said the recent jump in recalls most likely relates not to an increase in manufacturing issues, but increased oversight: In-person F.D.A. inspections have ramped back up after declining early in the Covid-19 pandemic. Dr. Novack added that he has observed stepped-up regulatory scrutiny of eye care products after a February 2023 recall of imported eye drops that affected dozens.
“One of the principles of inspections is that the more problems you find, the deeper you have to dive,” Dr. Novack said.
Are recalled eye drops and ointments dangerous?
Contaminated products can “lead to eye infections that can be very serious, sight-threatening, or even life-threatening,” said Dr. Corson. The February 2023 recall, which involved several eye-care products contaminated with bacteria, was linked to 14 cases of vision loss and at least four deaths. Four patients also had to have surgery to remove their eyes.
However, experts emphasized that adverse outcomes tied to eye products — and especially serious issues such as vision loss — remain rare.
“Most of the recalls have been done proactively, prior to any outbreaks or any known infections,” said Dr. Christopher Starr, an associate professor of ophthalmology at Weill Cornell Medicine.
If you’re worried that your eye drops or ointments are unsafe, search for them on the F.D.A.’s recall list, and dispose of the product if it has been recalled. If you experience eye pain or redness, blurry vision or extra sensitivity to light, experts said that you should see an eye doctor, as these can be symptoms of an infection. Dr. Starr said anyone who experiences these issues seek care, regardless of whether they’ve used a recalled product.
How can you use eye drops and ointments safely?
Dr. Starr emphasized that people do not need to stop using their eye drops or ointments out of fear of potential recalls. If your doctor recommends or prescribes a product, or it eases your symptoms, you should continue to use it. He added that while some of the recalled eyedrops have been preservative-free products, the issues stemmed from manufacturing processes, not a lack of preservatives.
“People don’t need to toss out all their preservative-free vials if they’re not on the recall list,” he said.
When using any eye product, there are a few general rules to do so safely. The first is to look out for any signs of contamination, including discoloration, cloudiness or an odor other than a product’s typical scent.
Dr. Starr also recommended that people who use eye drops clean the bottle’s tip by sterilizing it with an alcohol wipe, which can help prevent contamination. You should also look for any cracks in the bottle, especially around the dispenser, because they can allow bacteria into the product. And be sure to check the expiration date: Even perfectly sterile eye drops or ointments can become contaminated through use over time. If your product is expired, “just toss it out and start fresh,” Dr. Starr said. “You’re preventing eye problems, which is certainly priceless.”