Millions of eye drops recalled nationwide due to potential foreign substance

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NEW YORK (WPIX) – Millions of bottles of eye drop medication widely used to treat allergies and inflammation have been recalled across the country, according to the Food and Drug Administration.

Prednisolone Acetate Ophthalmic Suspension eye drops were recalled due to the potential presence of a foreign substance, according to the recall notice.

Lupin Pharmaceuticals Inc., the manufacturer of the prescription drug, is voluntarily recalling more than 2.5 million bottles of its product.

“Prednisolone is a steroid medicine that is used to relieve the redness, itching, and swelling caused by eye infections and other conditions,” reads a description of the medication from the Mayo Clinic. “This medicine is available only with your doctor’s prescription.”

Recall information

Product description: prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only

5 mL (NDC 70748-332-02)

10 mL (NDC 70748-332-03)

15 mL (70748-332-04)

Manufactured by:  Lupin Limited, Pithampur (M.P) 454 775, INDIA

Product Quantity: 2,530,182 bottles

Recall Number: D-0655-2026

The recall, which was initiated early last month but classified as a Class II recall last week, spans dozens of individual lot codes and separate bottles. To see if your prescription is affected, click here.

In the case of a Class II recall, use of or exposure to a product may cause temporary or medically reversible adverse health consequences, according to the FDA.

Nexstar’s WPIX reached out to Lupin Pharmaceuticals Inc., but they were not immediately available to comment.

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