Sun Pharma and Zydus Recall Products in the US: USFDA Report

New Delhi, Mar 16 (PTI) Sun Pharma and Zydus Pharmaceuticals are recalling products in the US market due to manufacturing issues, according to the US Food and Drug Administration (USFDA).

The New Jersey-based Sun Pharmaceutical Industries, Inc is recalling 9,840 bottles of Morphine Sulfate extended-release tablets for “Failed Dissolution Specifications”, the US health regulator stated in its latest Enforcement Report.

The company initiated the Class II nationwide (US) recall on February 6, 2025.

USFDA stated that Zydus Pharmaceuticals (USA) Inc is recalling a lot of Nelarabine Injection, used in the treatment of certain cancers, in the US.

The company is recalling 36,978 vials of Nelarabine Injection in strength of 250mg/50mL, (5mg/mL) for “Failed Impurities/ Degradation Specifications,” USFDA stated. The company initiated the Class II recall 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.

Indian pharmaceutical companies supply a substantial proportion of drugs to US residents, with four out of ten of all prescriptions filled in the US in 2022 being supplied by Indian companies.

As per industry estimates, overall, medicines from Indian companies provided USD 219 billion in savings to the US healthcare system in 2022 and a total of USD 1.3 trillion between 2013 and 2022.

Generics from Indian companies are expected to generate an additional USD 1.3 trillion in savings over the next five years.