FDA Recalls 2.5 Million Lupin Prednisolone Eye Drops Due to Contamination

Lupin Pharmaceuticals Recalls 2.5 Million Bottles

Lupin Pharmaceuticals has initiated a voluntary nationwide recall of more than 2.5 million bottles of Prednisolone Acetate Ophthalmic Suspension, USP 1%. The move follows reports of potential contamination with a foreign substance. According to the U.S. Food and Drug Administration (FDA) enforcement report, the recall spans multiple lot numbers of 5 mL, 10 mL, and 15 mL bottles with expiration dates reaching through March 31, 2028.

Class 2 Classification and Safety Risks

The FDA has classified this as a Class 2 action. This designation indicates that the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious health risks is remote. While the enforcement report confirms the presence of a foreign substance, it does not explicitly identify the nature of the contaminant.

Prednisolone Acetate is a prescription-strength corticosteroid used to treat eye inflammation, redness, and itching caused by allergies or non-infectious conditions.

Verifying Your Medication

Patients currently using these eye drops should immediately check their medication against the official recall list.

• Check the Label: Inspect your bottle for the manufacturer name, Lupin Pharmaceuticals, and the product name, Prednisolone Acetate Ophthalmic Suspension, USP 1%.
• Verify Lot Numbers: Access the full FDA Enforcement Report to cross-reference your specific lot number and expiration date.
• Consult Your Pharmacy: If you are unsure whether your medication is part of the recall, contact your pharmacist. They can confirm if your specific prescription was filled using an affected lot.

Immediate Steps for Patients

If you possess a bottle included in this recall, do not use the medication. The FDA advises patients to stop using the product immediately and return it to the pharmacy where the prescription was filled for proper disposal or replacement.

Manufacturing Integrity and Product Appearance

Prednisolone Acetate is a potent anti-inflammatory medication.