If you use prescription prednisolone acetate 1% eye drops, check the NDC and lot with your pharmacist — and because this is a prescribed medicine, ask about a replacement rather than simply going without it.
What Is Being Recalled?
Lupin is recalling more than 2.5 million bottles of Prednisolone Acetate Ophthalmic Suspension, USP, 1% — a prescription steroid eye drop used to treat inflammation of the eye — because of possible foreign-substance contamination. The recall covers three bottle sizes across many lot numbers: 5 mL (NDC 70748-332-02), 10 mL (NDC 70748-332-03), and 15 mL (NDC 70748-332-04), with expiration dates ranging from July 2026 through March 2028. The affected product was manufactured at Lupin's facility in Pithampur, India.The company initiated the recall in early June 2026, and the U.S. Food and Drug Administration (FDA) classified it as a Class II recall. A Class II designation means exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious harm is remote. Because the affected drops are dispensed by prescription, the practical first step for most patients is to confirm the NDC and lot with their pharmacy.
Why a Contaminated Eye Drop Is a Concern
Eye drops are applied directly to the surface of the eye, so sterility matters. When a sterile ophthalmic product may contain foreign material, regulators act quickly because the eye has limited defenses against contaminants and infection or irritation can follow. This recall is a precautionary, quality-driven action tied to the possible presence of foreign substances in the product — not a report that a specific injury has occurred.Prednisolone acetate is a corticosteroid drop prescribed to reduce inflammation after eye surgery or during certain eye conditions. It is not a product patients should abruptly stop without guidance, which is why the safest path is to reach your pharmacist or prescriber for a replacement supply.
What to Do If You Have the Recalled Drops
• Check the label for the product name (Prednisolone Acetate Ophthalmic Suspension 1%), the NDC (70748-332-02, -03, or -04), and the lot number. Your pharmacy can confirm whether your bottle is in the recall.• Stop using a recalled bottle. Do not continue to instill drops from a bottle identified in the recall.
• Contact your pharmacist or prescribing doctor about a replacement. Because this is a prescription steroid, ask about continuing your treatment rather than simply going without it.
• If you experience eye pain, redness, discharge, or vision changes, seek medical care.
For the full list of affected lot numbers, refer to the FDA's enforcement report entry for this recall.
Is There a Refund, Claim Form, or Lawsuit?
No. This is an FDA drug recall — a corrective action to remove potentially defective product from the market — not a class action settlement. There is no cash fund, no claim form, and no online refund portal to submit. Patients who paid out of pocket should ask their pharmacy about a replacement or credit. No documentation is required simply to stop using and discard the product.If you want to compare this with consumer litigation over eye-care products, see our coverage of the Alcon Systane preservative-free eye drops lawsuit, which is a separate matter from this Lupin recall.
Frequently Asked Questions
What eye drops did Lupin recall?
Prescription Prednisolone Acetate Ophthalmic Suspension 1% in 5 mL, 10 mL, and 15 mL bottles (NDC 70748-332-02, -03, and -04), across many lot numbers with expirations from July 2026 to March 2028. The product was made at Lupin's Pithampur, India facility.
Why were they recalled?
Because of possible foreign-substance (foreign material) contamination. The FDA classified it as a Class II recall.
What should I do?
Stop using a recalled bottle and contact your pharmacist or doctor about a replacement — this is a prescription medicine, so do not simply go without it. Your pharmacy can confirm whether your bottle's NDC and lot are in the recall.
Is there a refund or claim form?
No. This is a drug recall, not a settlement — there is no fund, claim form, or online refund portal. Ask your pharmacy about a replacement or credit. No documentation is needed to discard the product.
Sources
- FDA — Recalls, Market Withdrawals & Safety Alerts (Enforcement Reports)
- Fierce Pharma — Lupin Recalls More Than 2.5M Bottles of Eye Drops
- Fox Business — FDA Issues Class II Recall for Lupin Steroid Eye Drops
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