Dr Reddy’s and Zydus Recall Products in US Over Quality Issues

Two leading Indian pharma companies, Dr Reddy’s Laboratories and Zydus Lifesciences, have initiated Class II recalls in the United States due to manufacturing and quality concerns. Dr Reddy’s is recalling 571 vials of Succinylcholine Chloride Injection after stability testing revealed out-of-specification results. The nationwide recall was initiated on September 26. Zydus Pharmaceuticals (USA) Inc. has recalled over 1,500 bottles of Entecavir tablets (used for chronic hepatitis B) due to failed impurity/degradation specifications—912 bottles of 0.5mg and 600 bottles of 1mg strength—starting September 24. The US FDA classifies both as Class II recalls, meaning use may cause temporary or reversible health effects, with low risk of serious harm. These recalls underscore the stringent regulatory environment in the US and the critical importance of quality control in pharmaceutical manufacturing. Both companies are taking corrective actions to comply with FDA standards. Patients are advised to consult healthcare providers for alternative treatments.