Glenmark Pharmaceuticals Faces FDA Action after Report Links Its Generic Drug to US Deaths

Patricia Callahan (ProPublica) 28 July 2025

Economy & Nation

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 US.

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, a disciplinary tool the regulator uses to lay out significant violations of federal requirements and demand changes. If Glenmark fails to fix any of the problems outlined, the FDA warned, it may bar drugs made at the factory from entering the US.

What’s more, the FDA pointed out that the company had made similar serious mistakes at three other manufacturing sites and acknowledged that those factories had been the subject of previous warning letters from the agency since 2019. The problems at one were so severe that federal regulators blocked drugs made there from being imported to Americans. ProPublica’s December investigation highlighted this pattern, noting that three of the five factories where Glenmark made drugs for the US market in recent years had been in trouble with federal regulators. Despite that track record, the FDA — backlogged from the pandemic — waited five years before sending its inspectors back to the Madhya Pradesh plant.

In his 11th July warning letter, the director of the FDA’s Office of Manufacturing Quality wrote, “These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate.” (The agency made the letter public last week.)

“You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements,” he added.

A spokesperson for the company said in a written statement: “Glenmark is actively engaging with the US FDA and has initiated corrective actions to address the agency’s observations. Patient safety, product quality and regulatory compliance are foundational to how we operate.”

Citing ongoing litigation the company faces, she declined to comment further.

ProPublica has been investigating the FDA’s oversight of foreign factories that make generic drugs for the U.S. market.

Since last year, ProPublica repeatedly has asked the FDA why it didn’t send inspectors to the Glenmark factory sooner, given the outsized share of recalls and the company’s troubled track record at its other plants. The agency hasn’t answered the question. After the inspection found problems this year, an FDA spokesperson said the agency can only discuss potential or ongoing compliance matters with the company involved.

Among the most serious violations outlined in the FDA letter to Glenmark was the company’s failure to promptly test pills to ensure they dissolve properly during their normal shelf life, the subject of ProPublica’s investigation last year. Continue Reading…

Courtesy: ProPublica

Comments

User

Meenal Mamdani

3 months ago

But is Glenmark allowed to sell these drugs within India?
If the drugs are dangerous for American patients then they are dangerous for people in India too.
Why is Glenmark not penalized for this?

Kamal Garg

Replied to Meenal Mamdani comment 3 months ago

Valid question must be answered.