More than two million bottles of eye drops were voluntarily recalled this month after the discovery of a “foreign substance” that might have compromised the safety of the medication.
The steroid eyedrops in question are a generic medication, often prescribed to patients to reduce inflammation after surgery or to treat irritation. While the Food and Drug Administration has provided few details about how the recalled drops could harm consumers, the agency said the risk of severe injury was “remote.”
As of Friday, there had been no reports of injuries from the recalled drops, which were manufactured in India by Lupin Pharmaceuticals. The company did not immediately return a request for comment.
There have been a spate of eye drop and ointment recalls in recent years, including one in 2023 that was linked to four deaths. Part of the problem is that generic prescription medications — like the recalled eyedrops — are increasingly manufactured abroad, where there is not as much oversight, said Dr. Mark Blecher, chief physician executive at the Wills Eye Hospital in Philadelphia.
He said he expected this problem to worsen in light of recent budget cuts at the F.D.A., which have affected the part of the agency responsible for inspecting foreign drug manufacturers.
“The U.S. has not done a great job in regulating these companies,” he said. “But it’s getting actively worse as we speak.”
Problems with eye products can be particularly dangerous, because the eye does not have the same defenses against bacteria or viruses that the stomach does, said Gary Novack, professor of ophthalmology at U.C. Davis School of Medicine.
“Introducing a contaminant or bacteria here is kind of the equivalent of placing it directly onto an open wound,” said Dr. Ami Vadada, an ophthalmologist and a spokeswoman for the American Academy of Ophthalmology.
The recalled drops are labeled as prednisolone acetate ophthalmic suspension. If you are concerned that eye drops you use might have been affected, compare the lot number on your bottle to the F.D.A.’s recall notice, or call a pharmacist.
People who have used the recalled drops should throw away the bottle and immediately reach out to an eye doctor for a replacement. Dr. Vadada warned that people should not abruptly stop using steroid eyedrops, which can lead to a rebound of intense eye inflammation.
Dr. Novack said this recall was not a reason to stop using other kinds of eye products, especially if they have been prescribed by a doctor. In fact, he said it was reassuring that the company informed the F.D.A. and the public that there was a problem.
“This is the system working normally,” he said.
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