Lupin Pharmaceuticals, the U.S. unit of India’s Lupin Limited, issued a voluntary recall of more than 2.5 million bottles of prednisolone acetate ophthalmic suspension after an undisclosed contaminant was discovered.
The recall of the prednisolone eye drops, a prescription steroid used to treat swelling, redness and itching, was initiated by the company on June 4, according to a posting on the FDA’s webpage.
The action has been designated as a Class II recall, meaning the product is defective but not inherently life-threatening. The eye drops were manufactured at Lupin’s Pithampur, India, production site, and distributed nationwide in the U.S. The bottles came in 5- 10- and 15-ml doses, per the FDA notice.
The official reason listed for the recall is stated as "Presence of Foreign Substance," although the notice did not clarify how much of Lupin's product is affected or how the issue was identified.
As of last week, the FDA's enforcement report had not flagged any adverse effects related to the recall.
The recall comes almost exactly three years after Lupin issued a recall in August 2023 for two lots of birth control pills due to the potential that they may not be effective in preventing pregnancy.
Six months earlier than that, Lupin was hit with a Form 483 at its active pharmaceutical ingredients plant in Mandideep, India, marking the fourth such admonition it received from the regulatory agency in a nine-week period.
More recently, amid a U.S. onshoring boom, the company has sketched out designs on a $250 million production plant in Coral Springs, Florida. The company's U.S. headquarters is situated in Naples, Florida, roughly 100 miles west of the facility-in-waiting.