Glenmark Recalls Products in U.S. Over Quality Concerns, Says FDA

Indian drugmaker Glenmark Pharmaceuticals is voluntarily recalling nearly 27,000 packs of its oral contraceptive tablets from the U.S. market following a manufacturing issue, according to a recent U.S. Food and Drug Administration (USFDA) report.

The recall, initiated by Glenmark’s U.S. subsidiary in Mahwah, New Jersey, affects one lot of Viorele — a combination of Desogestrel and Ethinyl Estradiol (USP 0.15 mg/0.02 mg) and Ethinyl Estradiol tablets. The action was taken after the batch failed impurities and degradation tests, indicating a potential quality issue that could impact the drug’s stability and effectiveness.

The USFDA’s Enforcement Report highlights the recall as a Class II recall, suggesting the product’s use may cause temporary health issues or pose a slight risk of serious harm under certain conditions.

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