Eyewire+FDA Recalls More than 2.5 Million Bottles of Prednisolone Acetate Eye Drops

📋 Regulatory Action / Label Change

More than 2.5 million bottles of Lupin’s prednisolone acetate ophthalmic suspension have been recalled nationwide after reports of a foreign substance in the product. The FDA classified the action as a Class II recall, indicating potential for temporary or medically reversible adverse health consequences.

Professional Impact

• Recall affects 5-mL, 10-mL, and 15-mL bottles of prednisolone acetate ophthalmic suspension 1%.
• Prednisolone acetate remains a commonly prescribed corticosteroid for postoperative inflammation, uveitis, and allergic ocular disease.
• Clinicians may receive increased patient inquiries regarding affected NDCs, lot numbers, and replacement therapy options.
• The FDA advises verification of product identification details before continued use of recalled inventory.

Action Items

• Review office and pharmacy inventory for affected NDCs and lot numbers.
• Document patient reports potentially related to recalled products.
• Update patients using affected bottles on recall status and next steps.
• Monitor FDA communications for additional recall information or guidance.