The Food and Drug Administration (FDA) has issued a recall of nearly 40 different generic medications produced by Glenmark Pharmaceuticals Inc. The recall was initiated on March 13 and given a Class II risk level on April 8 due to the medications failing to meet “current good manufacturing practice.”
These medications, used to treat various conditions such as high blood pressure, cholesterol, seizures, and more, were manufactured at a Glenmark Pharmaceuticals factory in India. The recall includes drugs like Fenofibrate Capsules, Propafenone Hydrochloride Capsules, Solifenacin Succinate Tablets, and many others.
The FDA found that the manufacturing site in India did not meet quality standards, leading to cross-contamination between medications, lack of contamination prevention measures, and discrepancies in batch reviews and testing methods. The recalled medications have been classified as Class II, meaning they could cause temporary or reversible adverse health consequences.
While the FDA did not report any injuries or adverse events linked to the recalled drugs, it’s advised that individuals who have these medications stop taking them and consult their physician for alternative options. This is not the first time Glenmark Pharmaceuticals has faced issues with their products, as a previous investigation in 2024 revealed problems with extended-release potassium chloride medication which led to deaths and hospitalizations.
Consumers can find more information on the recall, including lot numbers and expiration dates, on the FDA’s enforcement report. The agency did not provide specific guidance in their report, but it is crucial for individuals to prioritize their health and safety when it comes to medication.