Lupin recalls 2.5M prednisolone eye drop bottles in United States due to foreign substance concerns

USA—Lupin Pharmaceuticals, the U.S. subsidiary of India’s Lupin Limited, has voluntarily recalled more than 2.5 million bottles of its prednisolone acetate ophthalmic suspension after detecting an undisclosed foreign substance. 

The recall, which the company initiated on June 4, involves prescription steroid eye drops commonly used to relieve inflammation, redness, itching and swelling associated with various eye conditions.

The U.S. Food and Drug Administration (FDA) later published the recall in its enforcement report.

Class II recall covers multiple bottle sizes

The FDA has classified the action as a Class II recall, indicating that the affected product may cause temporary or medically reversible adverse health effects, although the likelihood of serious health consequences remains low.

According to the FDA notice, the recalled eye drops were manufactured at Lupin’s production facility in Pithampur, India, before being distributed throughout the United States.

The affected products were packaged in 5 ml, 10 ml, and 15 ml bottles.

The agency listed the reason for the recall as the “presence of foreign substance.”

However, neither the FDA nor Lupin disclosed the nature of the contaminant, how it entered the product, or how the issue was detected.

The notice also did not specify whether all production batches were affected.

As of the FDA’s latest enforcement report, regulators had not received any reports of adverse events linked to the recalled eye drops.

Recall adds to previous regulatory challenges

The latest action comes nearly three years after Lupin recalled two batches of oral contraceptive pills in August 2023 because the products might not have provided effective pregnancy prevention.

Earlier that year, the company also received a Form 483 inspection report from the FDA following an inspection of its active pharmaceutical ingredient manufacturing facility in Mandideep, India.

The observation marked the fourth Form 483 issued to Lupin by the U.S. regulator within a nine-week period, highlighting a series of manufacturing compliance concerns across its operations.

Company continues U.S. manufacturing expansion

Despite the recent regulatory actions, Lupin continues to expand its manufacturing footprint in the United States.

The company has announced plans to invest US$250 million in the construction of a new pharmaceutical manufacturing facility in Coral Springs, Florida.

The investment aims to strengthen domestic production capacity as pharmaceutical companies increasingly expand manufacturing operations within the U.S.

Lupin Pharmaceuticals operates its U.S. headquarters in Naples, Florida, approximately 100 miles from the planned Coral Springs facility, which forms part of the company’s broader strategy to support its growing presence in the American pharmaceutical market.