Summary: Lupin Pharmaceuticals has recalled more than 2.5 million bottles of Prednisolone Acetate Ophthalmic Suspension, USP, 1% (5 mL, 10 mL and 15 mL) after an FDA enforcement report identified possible contamination with an unidentified substance. The recall, classified as Class 2, covers bottles with expiration dates through 03/31/2028 (Event No. 99144, posted June 30, 2026). Patients should not use recalled drops and should return them to the dispensing pharmacy or dispose of them safely; seek medical care for severe eye symptoms.
Nationwide Recall: 2.5M+ Lupin Prednisolone Eye-Drop Bottles Recalled Over Possible Contamination
eyedrop bottles in front of a blue and green background with the world "recall" repeating.Everyday Health
More than 2.5 million bottles of prescription prednisolone eye drops made by Lupin Pharmaceuticals have been recalled nationwide after a U.S. Food and Drug Administration (FDA) enforcement report raised concerns about possible contamination with an unidentified foreign substance. The FDA report did not specify the nature of the contaminant.
What Was Recalled?
Product: Prednisolone Acetate Ophthalmic Suspension, USP, 1% (steroidal eye drops)
Packaging: 5 mL, 10 mL, and 15 mL bottles
Expiration Dates: Through 03/31/2028
Monroe-Hammond-article
Recall Classification: Class 2 recall (may cause temporary or medically reversible adverse health consequences; probability of serious adverse health consequences is remote)
Full lot numbers and affected lots are listed in the FDA enforcement report (Event No. 99144, posted June 30, 2026). Consumers should check that report or contact their pharmacy or prescriber to confirm whether their bottle is part of the recall.
What Patients Should Do
- Do not use any recalled bottles.
- Return the product to the pharmacy that dispensed it for guidance, or follow local medication-disposal recommendations to discard it safely.
- If you used a recalled bottle and experience any concerning symptoms—such as severe eye pain, sudden vision changes, persistent redness, increased discharge, or significant irritation—seek medical attention immediately.
Why This Matters
Prednisolone ophthalmic drops are prescription steroid medications used to reduce itchiness, redness and swelling caused by noninfectious eye inflammation and allergic conditions. Contamination of ophthalmic products can increase the risk of eye irritation or infection, which is why the FDA and manufacturer issued this recall.
Reference: FDA Enforcement Report, Event No. 99144 (June 30, 2026). See the FDA report for a complete list of recalled lot numbers and additional details.
If you have questions about replacement therapy or alternatives, contact your eye care provider or pharmacist. For more detailed clinical information about prednisolone eye drops, consult trusted medical sources such as the Mayo Clinic or speak with a clinician.
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