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Indian pharmaceutical giants Sun Pharma and Zydus Pharmaceuticals are recalling certain products from the US market due to manufacturing concerns, according to the latest Enforcement Report from the US Food and Drug Administration (USFDA).

Sun Pharmaceutical Industries, Inc., based in New Jersey, has recalled 9,840 bottles of Morphine Sulfate extended-release tablets due to “Failed Dissolution Specifications.” The company initiated a Class II nationwide recall in the US on February 6, 2025.

The USFDA also stated that Zydus Pharmaceuticals (USA) Inc is recalling a lot of Nelarabine Injection, a drug used to treat certain cancers. A total of 36,978 vials of Nelarabine Injection (250mg/50mL, 5mg/mL) are being recalled due to “Failed Impurities/Degradation Specifications.” In addition, Zydus is recalling another 1,893 vials of the drug in the same strength. The Class II recall was initiated on February 13, 2025.

A Class II recall is issued when the use of a violative product may lead to temporary or medically reversible adverse health effects, with a low probability of serious health consequences.

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