Glenmark Sun Pharma Zydus Recall Over 40 Products in US Amid Safety Concerns

Indian pharmaceutical giants Glenmark, Sun Pharma, and Zydus are recalling over 40 products in the US due to manufacturing issues, as per the US Food and Drug Administration (USFDA).

Mumbai-based Glenmark initiated a Class II recall on March 13, 2025, for over 25 products, including Propafenone Hydrochloride capsules, Solifenacin Succinate tablets, and others, citing Current Good Manufacturing Practice (CGMP) deviations.

Sun Pharma’s US subsidiary recalled 13,700 bottles of Gabapentin capsules, a seizure medication, on March 4, 2025, due to cross-contamination concerns. The company classified this as a Class III recall.

Additionally, Zydus Pharmaceuticals (USA) pulled back 3,144 bottles of Chlorpromazine Hydrochloride tablets on April 3, 2025, after detecting N-Nitroso-Desmethyl Chlorpromazine impurities exceeding limits. This was categorized as a Class II recall.

USFDA explained that Class II recalls address products with temporary or reversible health risks, while Class III recalls involve minimal health consequences. These recalls highlight ongoing challenges with quality control in the global pharmaceutical supply chain.