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The FDA Is Cracking Down on an Indian Drugmaker Investigated by ProPublica Last Year

4 1
28.07.2025

by Patricia Callahan

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published.

The Food and Drug Administration is cracking down on a generic drugmaker that was the subject of a ProPublica investigation last year, citing problems with safety tests that delayed the recall of a medicine linked to deaths in the U.S.

In December, ProPublica reported that a Glenmark Pharmaceuticals factory in central India was responsible for an outsized share of recalls for pills that didn’t dissolve properly and could harm American patients. Among the string of recalls, federal regulators had determined that more than 50 million potassium chloride extended-release capsules sold in the U.S. could be deadly. Yet, federal drug inspectors at that point hadn’t set foot in the Madhya Pradesh factory for more than four years, ProPublica found.

Seven weeks after that story was published, FDA inspectors showed up at the plant and found serious problems. Glenmark subsequently recalled an additional two dozen medicines made there and sold to U.S. patients.

Now the FDA has sent Glenmark a warning letter,........

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