FDA Recalls 2.5M Bottles of Eyedrops Over 'Foreign Material'

A widely used steroid eye drop has been hit with a large recall involving more than 2.5 million bottles. Lupin Pharmaceuticals pulled multiple lots of its prescription prednisolone acetate 1% eye drops after foreign material was found in some bottles, per an FDA enforcement notice. The agency labeled it a Class II recall, meaning the risk of serious harm is considered remote but temporary or reversible health issues are possible, reports Fox Business.

The drops, made in India and distributed nationwide in 5, 10, and 15mL sizes, carry expiration dates beginning in July 2026. Prednisolone drops are available via prescription only, notes the Mayo Clinic. Patients are urged to check lot numbers against the FDA's recall list and consult a pharmacist or doctor before stopping use. Lupin began the recall June 4, but USA Today notes that it was reclassified as Class II on June 30. Bottles affected, with their national drug codes, include:

• PrednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only. 5 mL (NDC 70748-332-02)
• 10 mL (NDC 70748-332-03)
• 15 mL (70748-332-04)