Glenmark Pharmaceuticals has issued a recall for two dozen generic medications distributed to American patients. This decision follows a determination by the U.S. Food and Drug Administration (FDA) that the Indian manufacturing facility responsible for these drugs did not meet U.S. manufacturing standards and that the defective drugs could potentially harm consumers, according to federal records.
In February, the FDA identified cleaning and testing issues at the Glenmark facility in Madhya Pradesh, India. These issues were previously highlighted in a ProPublica investigation. The most recent recalls, disclosed in an FDA enforcement report last week, include a variety of commonly prescribed drugs treating epilepsy, diabetes, multiple sclerosis, heart disease, and high blood pressure. A comprehensive list of the recalled medications can be accessed through the FDA’s database.
The FDA stated that the faulty medications have the potential to cause temporary or reversible harm, although the risk of more severe issues is minimal. However, the FDA did not specify what symptoms might result from using the ineffective drugs. ProPublica sought additional details from the FDA and Glenmark, but neither responded.
Documents reveal that Glenmark initially notified wholesalers about the recall through a letter dated March 13. This communication suggested possible cross-contamination as the reason for the recall. Executive Director of Regulatory Affairs North America for Glenmark, Thomas Callaghan, mentioned that the affected medicines, totaling 148 batches, were manufactured in a facility shared with two cholesterol-lowering drugs, ezetimibe and a combination with simvastatin.
There is a particular concern due to ezetimibe’s chemical structure, which includes a beta-lactam ring—a feature associated with potentially severe allergic reactions, especially in antibiotics like penicillin. This property requires manufacturers to implement special measures to avoid cross-contamination, as per FDA regulations.
Callaghan noted that while the chemical nature of ezetimibe is unlikely to provoke such hypersensitivity reactions, Glenmark decided to recall the medications as a precaution based on an internal risk assessment. He confirmed that the FDA was informed about the recall process.
The potential contamination issue dates back several years. Records indicate Glenmark started distributing the drugs on October 4, 2022. ProPublica previously reported that the Glenmark plant was accountable for a disproportionately high number of U.S. recalls due to improperly dissolving pills, which posed health risks. Before the February inspection, the last FDA visit to the plant occurred prior to the COVID-19 pandemic, even though a previous recall was linked to fatalities among American patients.
Approximately two months after ProPublica’s investigation was published, the FDA conducted its first inspection of the plant in five years. During this visit, inspectors found that Glenmark had failed to sufficiently clean equipment to prevent drug contamination, and some medications were released to the market despite unreliable testing methods.
Furthermore, the inspection report revealed that Glenmark sometimes invalidated problematic test results and retried them with new samples until acceptable results were obtained, leading to their release in the U.S. The FDA’s detailed findings included a list of U.S.-bound drugs affected by potential contamination, but specifics were heavily redacted due to confidentiality concerns.
On March 7, ProPublica requested Glenmark’s response to the FDA inspection after obtaining the report via the Freedom of Information Act. Glenmark informed wholesalers of the recalls shortly thereafter, but neither the company nor the FDA conveyed details to ProPublica.
In a statement, a Glenmark spokesperson reiterated the company’s commitment to cooperating with the FDA to ensure compliance with manufacturing and quality standards. The FDA indicated it could only discuss compliance issues with the involved company.
The FDA publicly referenced the recalls in its April 8 enforcement report, an online repository for such notifications, although the recalls did not appear on its main recalls website, which hosts pharmaceutical companies’ press releases.
ProPublica questioned both the FDA and Glenmark on the lack of public alert regarding the recalls, but no response was received.
Glenmark is currently involved in a federal lawsuit claiming that recalled potassium chloride capsules from its Madhya Pradesh plant were linked to the death of a 91-year-old woman from Maine in June. The FDA had previously assessed that over 50 million of these capsules could potentially be fatal to U.S. patients due to improper dissolution leading to dangerous potassium spikes. Glenmark has denied responsibility for the woman’s death.
Following the potassium chloride recall, Glenmark informed federal regulators about reports of eight deaths in the U.S. related to the questionable capsules, as noted in FDA records. Pharmaceutical companies must report such incidents to facilitate ongoing drug safety monitoring by the FDA. However, the FDA provides limited detail, and as such, ProPublica could not independently verify specifics of each case. The agency clarifies that adverse event reports merely reflect the views of those reporting and do not confirm the drug as the cause.
