FDA Classifies Lupin Eye Drop Recall as Class II
More than 2.5 million bottles of a prescription steroid eye medication are being recalled nationwide after regulators classified the action as a Class II recall. Lupin Pharmaceuticals Inc. voluntarily initiated the recall of prednisolone acetate ophthalmic suspension USP, 1%, after foreign material was identified in certain lots, according to a Food and Drug Administration enforcement report.
The affected products were manufactured by Lupin Limited in Pithampur, India, and distributed nationwide. The recall covers 5 mL, 10 mL and 15 mL bottles sold under National Drug Codes 70748-332-02, 70748-332-03 and 70748-332-04. The FDA report lists dozens of lot numbers, with expiration dates beginning in July 2026 and extending beyond October 2026.
The FDA classified the recall on June 30 as Class II, a category used when exposure to a product may cause temporary or medically reversible health effects, or when the likelihood of serious health consequences is considered remote. Class I recalls involve products that may cause serious injury or death, while Class III recalls involve products unlikely to cause adverse health effects.
Prednisolone acetate ophthalmic suspension is a prescription corticosteroid eye drop commonly used to treat inflammation related to eye surgery, eye injuries and certain inflammatory eye conditions. Patients and health care providers are advised to check the FDA’s enforcement report to determine whether a specific bottle is included in the recall.
Individuals who believe they have an affected product should contact a pharmacist or medical provider to discuss confirmation, replacement medication or alternative treatment options. Patients should not stop using a prescribed medication without medical guidance.
Lupin began the recall on June 4 and notified customers by letter. The FDA said no press release has been issued. Details about the material and any adverse-event reports were not immediately publicly available.