Glenmark, Granules, Zydus and others recall medicines in US over quality issues: USFDA
Published on 28/09/2025 05:04 PM
Several Indian pharmaceutical companies including Glenmark, Granules India, Sun Pharma, Zydus and Unichem are recalling medicines from the US market, according to the US Food and Drug Administration (USFDA). The recalls are related to manufacturing issues, impurities, and labelling errors, according to the regulator's latest Enforcement Report.
Glenmark Pharmaceuticals is recalling 13,824 tubes of Azelaic Acid Gel, produced at its Goa plant, due to complaints of gritty texture.
The company's US arm initiated a Class II nationwide recall on September 17. Such recalls are made when the use of a product may cause temporary or reversible health issues, though the risk of serious problems is considered low.
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Granules India is also recalling over 49,000 bottles of a combination drug used for attention deficit hyperactivity disorder (ADHD).
The recall was initiated by its US arm on August 28 after the product failed impurity and degradation tests.
This is a Class III recall, which means the product is unlikely to cause harm.
Sun Pharma's US subsidiary has recalled 1,870 kits of a renal imaging agent following failed dissolution tests. This Class II recall was announced on September 3.
Similarly, Zydus Pharmaceuticals (USA) Inc, part of Ahmedabad-based Zydus, is recalling 8,784 bottles of antiviral drug Entecavir tablets due to impurity and degradation concerns.
The recall, also classified as Class II, was initiated on September 4. Unichem Pharmaceuticals USA Inc has issued a Class I recall for 230 bottles of medicine because of a label mix-up.
The company, based in East Brunswick, began the recall on August 27. A Class I recall is considered the most serious, as it could lead to significant health risks if patients take the wrong medicine.
However, India has the highest number of USFDA-approved pharmaceutical plants outside the United States.
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