Lupin Pharmaceuticals, the U.S. unit of India-based Lupin Limited, has issued a voluntary recall of more than 2.5 million bottles of prescription eye drops following the discovery of an undisclosed contaminant.
The recalled product is prednisolone acetate ophthalmic suspension, a steroid eye drop used to treat swelling, redness, and itching in patients.
The company initiated the recall on June 4, according to a posting on the FDA’s website, with the agency listing the official reason as “Presence of Foreign Substance.”
The FDA has designated the action as a Class II recall, meaning the product is considered defective but not inherently life-threatening to those who used it.
The eye drops were manufactured at Lupin’s production site in Pithampur, India, and were distributed to customers across the United States.
Affected bottles came in three sizes, specifically 5-millilitre, 10-millilitre, and 15-millilitre doses, according to the FDA notice posted online.
The FDA notice did not clarify how many units within the broader distribution are directly affected, nor did it explain how the contamination issue was initially identified.
This recall arrives almost exactly three years after Lupin issued a separate recall in August 2023 for two lots of birth control pills, citing concerns the products may not be effective in preventing pregnancy.
Six months before that 2023 recall, Lupin received a Form 483 at its active pharmaceutical ingredients plant in Mandideep, India, marking the fourth such regulatory admonition the company had received from the FDA within a nine-week period.
The latest recall adds fresh scrutiny to Lupin’s manufacturing operations at a time when the company is seeking to expand its footprint in the United States amid a broader domestic onshoring boom.
Lupin has outlined plans for a $250 million production facility in Coral Springs, Florida, signalling its ambition to deepen its manufacturing presence on American soil.
The prednisolone recall underscores the ongoing challenges facing pharmaceutical manufacturers in maintaining consistent quality standards across international production sites.
Regulators and industry observers continue to monitor the situation closely as Lupin works to resolve the contamination issue and address any outstanding compliance concerns.