The U. S.
Food and Drug Administration (FDA) has recalled more than 2.5 million bottles of generic prednisolone acetate ophthalmic suspension eye drops after reports of contamination.
>>> NASCAR Clears Bowman and Hamlin Cars After Chicagoland Inspection
The recall, initiated on June 4, 2026, covers 2,530,182 bottles distributed nationwide.
The FDA upgraded the action to a Class II recall on June 30, 2026, indicating that exposure could cause temporary or medically reversible adverse health effects, though serious harm is unlikely.
The eye drops are manufactured by India-based Lupin Limited and are the generic equivalent of Pred Forte.
They are used to treat allergies and eye inflammation, available in 5 mL, 10 mL, and 15 mL packages.
>>> Steve Cherundolo Appointed US Olympic Men's Soccer Coach for 2028 LA Games
The recall was triggered by a single market complaint about particulate matter.
A health hazard assessment determined that the foreign substance could lead to corneal injury, mechanical irritation, and secondary ocular inflammation.
Distributor Hilco Vision sent immediate recall notifications to customers, identifying affected lot numbers 1315797 and 1315798.
Healthcare providers were advised to stop using the medication, quarantine existing inventory, and notify all staff and consumers who received the specified lots.
>>> European Parliament Approves Next Phase for Digital Euro Development
The FDA's MedWatch Adverse Event Reporting program is collecting reports of any additional contamination or patient infections.
