The FDA found concerns at a factory in India that makes generic drugs for U.S. patients including one drug that was manufactured at the facility and has been linked to at least eight deaths, ProPublica reported March 20.
The agency conducted an inspection of the factory after a December ProPublica investigation revealed that the Glenmark Pharmaceuticals-operated plant was linked to a disproportionate amount of recalls for improperly dissolving pills that could pose health risks.
Among the recalls, the agency found last year that more than 50 million potassium chloride extended release capsules had the potential to be fatal to U.S. patients. Still, the agency had not sent inspectors to the factory in Madhya Pradesh, India, since before the COVID-19 pandemic, the report said.
When FDA inspectors visited the Glenmark plant in February 2025, five months following the prior inspection, the agency found problems with cleaning and testing of medications that were already shipped to U.S. consumers.
In a report detailing the agency’s findings, inspectors said, “Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.”
An FDA spokesperson would not tell the news outlet why the agency waited so long to inspect the factory or what federal regulators will require for Glenmark Pharmaceutical’s to fix the issue. A spokesperson for Glenmark declined ProPublica’s request for comment on the inspection, citing ongoing litigation.
