Millions of prescription eye drops recalled nationwide over contamination concerns

More than 2.5 million bottles of a prescription steroid eye medication are being recalled nationwide after the Food and Drug Administration classified the action as a Class II recall over concerns about foreign material found in the product.

Lupin Pharmaceuticals Inc. voluntarily recalled 2,530,182 bottles of prednisolone acetate ophthalmic suspension USP, 1%, after the presence of a foreign substance was identified in certain lots, according to an FDA enforcement report.

The affected prescription eye drops were manufactured by Lupin Limited in Pithampur, India, and distributed nationwide. The recall includes 5 mL, 10 mL and 15 mL bottles sold under National Drug Codes 70748-332-02, 70748-332-03 and 70748-332-04.

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