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• Posted December 21, 2023

Eye Drop Recalls: What You Need to Know

Dozens of over-the-counter lubricating eyedrops and artificial tears faced recall in 2023, due to contamination and unsafe manufacturing practices.

"This year, we've seen an especially large number of recalls in ophthalmologic products,"said Gary Novack, a clinical professor with the UC Davis Health Department of Ophthalmology and Vision Sciences in Davis, Calif.

People who regularly use eye drops to fend off dry eyes or help with contact lenses should be aware of these recalls, and take steps to protect themselves, Novack said.

"Now that the public health emergency phase of the pandemic is over, the FDA is doing more inspections and they are finding a number of issues at manufacturing plants,"Novack explained in a university news release.

The recalls began in February with three brands taken off shelves, including one linked to serious infections, vision loss and four deaths, Novack said.

"It's very rare to get infections from eye drops. However, what we learned this year is that it can happen,"Novack said. "It's serious not only for potentially losing vision, but in some rare cases patients developed systemic infections and died."

Additional recalls followed in August, October and November, leaving consumers confused about whether any over-the-counter eye drops are safe to use.

Products like eye drops are particularly tricky to manufacture because they need to be sterile and germ-free, and they must be bottled in containers that are also sterile.

"That's been an issue for several products this year,"Novack said.

Novack said that any eye drops a person finds on their pharmacy or supermarket shelf should be considered safe, since the product hasn't been recalled.

"People may need to be more cautious if buying online, but the recalled products should have also been removed from online stores,"Novack added.

Keep in mind that most of the eye drops recalled in 2023 aren't familiar brand names, Novack added. They tended to be either store brands or little-known brands.

"To date, none of the recalled eye drops came from major ophthalmic pharmaceutical firms,"Novack said. "These include Alcon, which makes Systane; Bausch and Lomb, which makes SootheXP; Allergan, which makes Refresh; and Johnson & Johnson, which makes Blink. Some people may be more comfortable sticking with those brands."

In addition, no prescription eye drops have been recalled, Novack said. People using drops containing antibiotics, steroids or medications shouldn't worry about the recalls, and continue using their drops as prescribed.

Folks who find eye drops in their medicine cabinet should check to see if they're expired, and toss them out if they are, Novack said.

They then should check with their pharmacy, the manufacturer or the FDA's recall website to see whether the product in their possession has been taken off the shelf.

Novack emphasized that, while rare, eye problems resulting from the use of tainted eye drops can be potentially dangerous.

"Any sign or symptom of an eye infection, or any use of products that have been recalled, is a serious issue and patients should take this seriously,"Novack said.

More information

The U.S. Food and Drug Administration has more on eye drop recalls.

SOURCE: UC Davis Health, news release, Dec. 19, 2023