Lupin Pharmaceuticals is voluntarily recalling more than 2.5 million bottles of prescription steroid eye drops after the Food and Drug Administration found the potential presence of a foreign substance in the product.
The recall covers 2,530,182 bottles of Prednisolone Acetate Ophthalmic Suspension, USP, 1%, in 5-mL, 10-mL, and 15-mL sizes. The drops are manufactured by Lupin Limited at a facility in Pithampur, India. According to The Hill, prednisolone acetate is a prescription-only steroid that treats eye inflammation, infections, and related symptoms including irritation and swelling.
According to Yahoo, regulators first flagged the Lupin product on June 4; the Class II classification followed on June 30. That designation indicates that patient exposure could lead to health consequences that are temporary or can be resolved with medical intervention.
The recall includes many different lot codes for all three bottle sizes, with expiration dates from July 2026 to March 2028. If your prescription is from one of these lots, talk to your doctor or pharmacist before stopping the medication. Stopping prescription medicine without advice can be risky.
This is not the first large-scale eye drop recall in recent months. More than 3.1 million bottles of store-brand eye drops sold at CVS, Walgreens $WBA, Kroger, and other major retailers were recalled after the FDA cited a lack of assurance of sterility from their manufacturer, KC Pharmaceuticals of Pomona, California. That recall was also classified as Class II, with regulators saying serious harm was unlikely. No contamination was found and no injuries were reported in connection with that recall.
Unlike the KC Pharmaceuticals recall, which involved over-the-counter lubricating and artificial tear products, the Lupin recall covers a prescription-only steroid suspension used to treat inflammation and infection — a distinction that may affect how patients and pharmacies respond to the notice.