An Indian Drugmaker, Investigated by ProPublica Last Year, Has Recalled Two Dozen Medications Sold to U.S. Patients

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Glenmark Pharmaceuticals has withdrawn twenty-four generic drugs sold to American patients because the Indian factory that produced them did not meet U.S. manufacturing standards, and the Food and Drug Administration (FDA) found that the defective drugs could pose risks to people, according to federal records.

In February, the FDA identified issues with cleaning and testing at the facility in Madhya Pradesh, India, which was the focus of a ProPublica inquiry last year. The latest recalls, detailed in an FDA enforcement report last week, involve a variety of commonly prescribed medications, including those for epilepsy, diabetes, multiple sclerosis, heart disease, and high blood pressure, among other conditions. A complete list of the recalled drugs is accessible here.

While the agency concluded that the drugs could result in temporary or reversible harm, the likelihood of more severe issues was low. However, the FDA did not specify the symptoms that the flawed drugs might cause. ProPublica reached out to both the FDA and Glenmark for further information, but did not receive responses.

According to records, Glenmark initially notified wholesalers about the recalls in a letter dated March 13. The letter indicated that Glenmark withdrew the drugs due to possible cross-contamination. Thomas Callaghan, Glenmark’s Executive Director of Regulatory Affairs for North America, stated that 148 batches of the recalled medications were produced in a facility shared with two cholesterol-lowering drugs, ezetimibe and a combination of ezetimibe and simvastatin.

The presence of a beta-lactam ring in the chemical structure of ezetimibe raised concerns. While ezetimibe’s chemical structure suggests a low risk of causing hypersensitivity reactions, Glenmark decided to recall the drugs as a precautionary measure. The company stated that the recall was carried out with the knowledge of the FDA.

Glenmark informed wholesalers that the potential issue dated back to shipments that began on October 4, 2022. In December, ProPublica reported that the Glenmark facility was responsible for a significant number of U.S. recalls involving pills that did not dissolve properly and could pose risks to individuals. Following the investigation, FDA officials conducted their first inspection of the facility in five years and discovered various deficiencies in manufacturing practices.

Despite the detailed inspection report listing affected drugs, the FDA redacted information on specific medicines due to confidentiality concerns. ProPublica inquired about the inspection with Glenmark and the FDA, but did not receive responses. The FDA disclosed the recalls in an enforcement report on April 8, not on its public recalls website.

Glenmark is facing a lawsuit alleging that potassium chloride capsules manufactured at its Madhya Pradesh plant led to the death of a 91-year-old woman in Maine. Following a previous recall of Glenmark’s extended-release capsules, the company reported eight deaths in the U.S. related to the recalled capsules, but further details were not provided.

The FDA emphasizes that adverse event reports reflect the opinions of those reporting harm and do not establish causation.