THE NEW YORK TIMES – 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 …
