In the United States, more than 2.5 million bottles of a prescription steroid eye medication have been recalled due to contamination concerns. The recall was initiated by Lupin Pharmaceuticals Inc. on June 4, 2026, after the Food and Drug Administration (FDA) identified foreign material in certain lots of the product. The affected medication is prednisolone Acetate Ophthalmic Suspension USP, 1%, and the recall includes bottles of various sizes, specifically 5 mL, 10 mL, and 15 mL, sold under National Drug Codes 70748-332-02, 70748-332-03, and 70748-332-04. The FDA classified this recall as a Class II action on June 30, indicating that the use of the product may lead to temporary or medically reversible adverse health consequences, although the probability of serious adverse health consequences is considered remote. The recall encompasses numerous lot numbers with expiration dates starting in July 2026 and extending beyond October 2026. The products were distributed nationwide, and consumers are advised to check the FDA's published enforcement report to determine if their medication is affected. Patients who suspect they have an impacted bottle should consult their pharmacist or healthcare provider for guidance on replacement medication or alternative treatment options. It is crucial for patients not to discontinue their prescribed medication without professional advice. Lupin has communicated the recall to customers via letter, but the FDA has not issued a press release regarding the ongoing recall. As of the time of publication, inquiries to Lupin for further details, including the nature of the foreign material and any reported adverse events, have not been answered.
