Sun Pharma and Zydus Recall Products in the US, Says USFDA Report

The USFDA said that Sun Pharma and Zydus Pharmaceuticals are recalling products from the American market due to manufacturing errors. Sun Pharma Industries, Inc. based in New Jersey is recalling 9,840 bottles of Morphine Sulfate extended-release tablets for "Failed Dissolution Specifications," said the US health office in its latest Enforcement Report. The company began the Class II nationwide (US) recall on the 6th of February, 2025. As reported by the USFDA, Zydus Pharmaceuticals (USA) Inc. is recalling a lot of Nelarabine Injection, used to treat certain cancers, from the US. 

The company is recalling 36,978 vials of the injectable Nelarabine in a strength of 250 mg/50 mL, (5 mg/mL) for "Failed Impurities/Degradation Specifications," said the US FDA. The Class II recall was initiated by the company in February. Zydus is also recalling 1,893 vials of the drug in strength of 250mg/50mL, (5mg/mL). The company initiated the Class II nationwide recall on February 13 this year.As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. 

The proportion of medicines supplied by Indian pharmaceutical companies to the residents of the US was considerable, with four out of ten of all prescriptions filled in the country receiving medicines from Indian companies in 2022. Industry estimates have pegged the total medicines supplied by Indian companies to the American pharmaceutical industry at USD 219 billion in total savings in 2022, while overall the industry generated savings worth USD 1.3 trillion between 2013 and 2022 for the US healthcare department. Generic medicines from Indian firms are expected to accrue additional savings of USD 1.3 trillion over a period of the next 5 years.