Indian pharmaceutical behemoths Sun Pharma and Zydus Pharmaceuticals are voluntarily recalling certain batches of drugs from the US market based on quality-related manufacturing issues, according to the latest Enforcement Report released by the US Food and Drug Administration (USFDA).

Key Highlights
Sun Pharma Recall Details:

• Sun Pharmaceutical Industries, Inc., New Jersey, has started a Class II recall of 9,840 bottles of Morphine Sulfate extended-release tablets (15 mg).

• The recall was initiated because of "Failed Dissolution Specifications" and was initiated on February 6, 2025.

Zydus Pharmaceuticals Recall Information:
Two lots of Nelarabine Injection, which is utilized in the treatment of some types of cancer, are being recalled by Zydus Pharmaceuticals (USA) Inc. To be specific:

• 36,978 vials of Nelarabine Injection (250 mg/50 mL, 5 mg/mL)

• Another 1,893 vials of the same strength

• Both batches are recalled due to "Failed Impurities/Degradation Specifications." The Class II recall started on February 13, 2025.

Class II Recall Definition:
A Class II recall means that the product's use can lead to temporary or medically reversible adverse health consequences, but the risk of serious health effects is low.The Sun Pharma and Zydus Pharmaceuticals' recalls are an indication of the rigorous quality testing imposed by the USFDA for the safety of patients. Both firms are likely to resolve these production issues in order to avoid possible health hazards and remain in compliance with regulations in one of their biggest overseas markets.