Lupin Recalls 2.5 Million Bottles of Steroid Eye Drops

More than 2.5 million bottles of a widely prescribed steroid eye drop have been voluntarily recalled nationwide due to potential contamination with a foreign substance. The recall, initiated by Lupin Pharmaceuticals Inc. on June 4, 2026, affects its Prednisolone Acetate Ophthalmic Suspension, USP, 1%, a medication used to treat inflammation, redness, and swelling from eye infections and other conditions. The U.S. Food and Drug Administration formally classified the action as a Class II recall on June 30, indicating use of the product may cause temporary or medically reversible adverse health consequences.

The recalled bottles were manufactured by Lupin Limited at a facility in Pithampur, India, and distributed across the United States. The action covers 2,530,182 bottles across three package sizes: 5-milliliter, 10-milliliter, and 15-milliliter containers. Dozens of individual lot numbers are included, with expiration dates ranging from July 2026 through March 2028. The recall notice and the FDA's enforcement report have not specified the nature of the foreign substance identified. The company has not issued additional public statements detailing the contamination beyond the...