Published July 09, 2026
Millions of prescription eye drop bottles are being recalled across the United States after the Food and Drug Administration (FDA) identified the presence of a foreign substance in the product, posing potential health risks to consumers.
There was a voluntary recall conducted by Lupin Pharmaceuticals Inc. on 4 June 2006 of more than 2.5 million units of Prednisolone Acetate Ophthalmic Suspension, USP, 1%. This was declared by the FDA to be a Class II recall on 30 June 2006. It means that use of such products may result in temporary adverse health consequences.
The medicine commonly prescribed to relieve redness, itching, and swelling is frequently used after eye surgery.
The recall spans 2,530,182 bottles across three sizes, including 5ml, 10ml, and 15ml bottles, with dozens of individual lot codes affected.
To find out whether or not your eye drops have been recalled, search for the National Drug Code (NDC) number and lot code on your bottle. The recall covers 5 mL bottles with NDC 70748-332-02, 10 mL bottles with NDC 70748-332-03, and 15 mL bottles with NDC 70748-332-04, all of which have lot codes that begin with HA, HB, or HC. If your bottle falls under these categories, then you need to go over the full list of recalls to see if your lot number has been included in it.
Healthcare professionals and the FDA caution against abruptly discontinuing prescribed steroid eye drops, as doing so can cause complications from eye inflammation. Those who have affected bottles should consult their prescribing doctor or pharmacist for a replacement from an unaffected lot or an alternative medication.