Lupine Pharmaceuticals has recalled more than 2.5 million bottles of eye drops in the U.S. due to the presence of a foreign substance, according to a recall notice posted on the U.S. Food and Drug Administration website.
Prednisolone acetate eye drops were manufactured in India and come in 5ml, 10ml and 15ml bottles. The bottles have expiration dates ranging from July 31, 2026 to March 31, 2028, according to the FDA website.
Eye drops are used to treat eye irritation, redness, and swelling, as well as eye infections. People often use prednisolone eye drops for allergies. It is unclear what “foreign substance” may have contaminated the eye drops and how the substance was discovered.
It is also unclear if there have been reports of injuries. Lupine Pharmaceuticals did not immediately respond to emailed questions Thursday.
The recall was initiated in early June, but was recently granted a Class II recall status, defined by the FDA as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the likelihood of serious adverse health consequences is remote.”
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Earlier this year, more than 3 million bottles of eye drops were recalled over concerns about sterility. The eye drops were manufactured by KC Pharmaceuticals in Pomona, California, and sold under a variety of brands for stores like CVS, Kroger and Walgreens.
In 2023, thousands of eye drops were recalled by US Pharma out of concern that their eye drops could cause infections that could lead to blindness. Contaminated eye drops also killed at least 4 people in 2023 and caused more than a dozen cases of vision loss, according to University of California, Davis Health.
