Lupin recalls 2.5M eye drop bottles

Lupin Pharmaceuticals Inc., a subsidiary of Lupin (company), voluntarily recalled over 2.5 million bottles of Prednisolone Acetate Ophthalmic Suspension, USP, 1% (a prescription steroid eye drop) due to potential presence of a foreign substance. The recall was initiated on June 4, 2026, and classified as Class II by the U.S. United States — Food and Drug Administration (FDA) on June 30, 2026. The affected products were manufactured at Lupin's facility in Pithampur, India, and distributed nationwide in the United States. The recall covers 5 mL, 10 mL, and 15 mL bottles with multiple lot codes and expiration dates ranging from July 2026 to March 2028. Patients are advised to consult their healthcare provider before discontinuing use. This recall follows a previous large-scale recall of over-the-counter eye drops from KC Pharmaceuticals in 2025.