Overview
- Lupin initiated a voluntary recall on June 4 and the FDA listed the action as a Class II recall on June 30 covering 2,530,182 bottles of prednisolone acetate ophthalmic suspension.
- The recall covers 5 mL, 10 mL and 15 mL bottles with NDCs 70748-332-02, 70748-332-03 and 70748-332-04 and dozens of lot numbers with expiration dates from July 31, 2026 to March 31, 2028.
- The stated reason is the “presence of foreign substance,” but the agency and manufacturer have not disclosed the contaminant or reported any confirmed injuries.
- The FDA advises immediate cessation of use of recalled bottles and urges patients to contact their prescribing clinician or pharmacist for replacement or alternative therapy because stopping steroid eye drops without guidance can worsen inflammation.
- The recall follows a string of recent ophthalmic product quality actions and raises concerns about sterility and supply for a drug commonly used after eye surgery and for inflammatory eye conditions.