Sun Pharma, Zydus recall products in US: USFDA
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The US Food and Drug Administration (USFDA) has said Sun Pharma and Zydus Pharmaceuticals are recalling products in the US market due to manufacturing issues.
In its latest Enforcement Report, the US health regulator said the New Jersey-based Sun Pharmaceutical Industries is recalling 9,840 bottles of Morphine Sulfate extended-release tablets for ‘failed dissolution specifications’.
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Revealing that the company initiated the Class II nationwide (US) recall on February 6, 2025, the USFDA reported 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’,” it informed, while divulging that the company initiated the Class II recall in February.
According to the USFDA, Zydus is also recalling 1,893 vials of the drug in strength of 250mg/50mL, (5mg/mL).
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