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FDA Recalls 2.5 Million Lupin Eye Drops Over Contamination

7/10/2026

Summary

FDA Recall

The U.S. FDA issued a Class II recall of 2,530,182 bottles of prednisolone acetate 1% eye drops after detecting a foreign substance.
Lupin Limited in Pithampur, India made the drops that Lupin Pharmaceuticals Inc. distributed, which the June 30 recall covers lot numbers expiring July 2026–Feb 2028 and NDC codes 70748-332-02, 70748-332-03, 70748-332-04.
Patients should verify lot numbers, consult a pharmacist before stopping, and seek care for pain, redness, swelling, vision changes, or infection.

Summary

Lupin Recall

Lupin issued a Class II recall of 132 batches of 5 mL, 36 batches of 10 mL and 22 batches of 15 mL eye-drop bottles expiring between July 31 2026 and February 29 2028.
The action follows K.C. Pharmaceuticals’ voluntary recall of over 3.1 million OTC eye-drop bottles sold at retailers including Walgreens and CVS.
The FDA classifies the Lupin recall as Class II, meaning exposure may cause temporary or reversible effects, thereby heightening scrutiny of eye-drop sterility.

Summary

Lupin Recalls

Lupin Pharmaceuticals voluntarily recalled its eye drops, acting on its own responsibility to protect public health.
USA TODAY contacted Lupin on July 9 for comment on the recall, but the company was not immediately available to respond.
The FDA’s enforcement report omitted a specific remedy for individuals who already have the recalled eye drops.
FDA policy requires manufacturers to notify customers who received the product and to give handling instructions.

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FDA Recall

The U.S. FDA issued a Class II recall of 2,530,182 bottles of prednisolone acetate 1% eye drops after detecting a foreign substance.
Lupin Limited in Pithampur, India made the drops that Lupin Pharmaceuticals Inc. distributed, which the June 30 recall covers lot numbers expiring July 2026–Feb 2028 and NDC codes 70748-332-02, 70748-332-03, 70748-332-04.
Patients should verify lot numbers, consult a pharmacist before stopping, and seek care for pain, redness, swelling, vision changes, or infection.

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