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FDA issues Class II recall for Lupin steroid eye drops after material found
Fox Business • • business
Key Points:
- Lupin Pharmaceuticals is voluntarily recalling over 2.5 million bottles of prednisolone acetate ophthalmic suspension USP, 1% due to the presence of foreign material, as classified by the FDA as a Class II recall.
- The recall affects various bottle sizes (5 mL, 10 mL, and 15 mL) distributed nationwide, with lot numbers expiring between July 2026 and beyond October 2026.
- Prednisolone acetate is a prescription steroid eye drop used to treat inflammation related to eye surgery, injuries, and certain inflammatory conditions.
- Patients with the affected medication are advised to consult healthcare providers for verification and replacement options but should not discontinue use without medical advice.
- Lupin began the recall process on June 4 and has notified customers, but the FDA report does not specify the nature of the foreign material or any reported adverse events; Lupin has not yet responded to requests for further information.
