The FDA has classified a recall of more than 2.5 million bottles of prescription prednisolone acetate eye drops as Class II after the product was found to contain a foreign substance.
The recall affects 2,530,182 bottles of Prednisolone Acetate Ophthalmic Suspension, USP, 1% in 5 milliliter, 10 milliliter and 15 milliliter presentations manufactured by Lupin Limited and distributed nationwide, according to a June 30 enforcement report.
The voluntary recall was initiated June 4 and classified by the FDA on June 30. It remains ongoing. The affected products include multiple lots with expiration dates ranging from July through October 2026.
The recall follows a similar one in March, when K.C. Pharmaceuticals recalled more than 3.1 million bottles of over-the-counter eye drops, including store-brand products sold at CVS Health, Walgreens, Kroger and Cardinal Health, after the company could not verify the sterility of the products.
