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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The FDA classified the recall as a Class II recall on June 30. According to the agency, a Class II recall is issued when use of a product may cause temporary or medically reversible adverse health consequences or when the probability of serious adverse health consequences is considered remote. Class I recalls involve products that could cause serious injury or death, while Class III recalls involve products that are unlikely to cause adverse health consequences.
The recall covers dozens of lot numbers with expiration dates beginning in July 2026 and extending beyond October 2026. According to the FDA, the products were distributed nationwide. Consumers and healthcare providers can compare affected lot numbers with the FDA’s published enforcement report to determine whether their medication is included in the recall.
Prednisolone acetate ophthalmic suspension is a prescription corticosteroid eye drop used to treat inflammation after eye surgery, eye injuries and certain inflammatory eye conditions.
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Patients who believe they have an affected bottle should contact a pharmacist or healthcare provider to determine whether the medication is included in the recall and discuss replacement medication or other treatment options. Patients should not stop using a prescribed medication without consulting a healthcare provider.
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Lupin initiated the recall June 4 and notified customers by letter. The FDA said no press release has been issued for the recall, which remains ongoing.
FOX Business has reached out to Lupin for additional information, including the nature of the foreign material found in the recalled products, whether any adverse events have been reported and what guidance the company is providing to patients. The company had not responded by publication time.
