Two leading Indian pharmaceutical companies, Sun Pharma and Zydus Pharmaceuticals, have recalled some of their medicines from the US market due to manufacturing concerns. The US Food and Drug Administration (USFDA) reported that the companies initiated the recalls after identifying issues related to dissolution and impurities in their products.
Sun Pharma Recalls Morphine Sulfate Tablets
Sun Pharmaceutical Industries, based in New Jersey, USA, has recalled 9,840 bottles of Morphine Sulfate extended-release tablets due to failed dissolution specifications. According to the USFDA Enforcement Report, the drug did not meet the required standards for dissolution, which affects how the medicine releases into the body.
The company initiated a Class II recall nationwide in the US on February 6, 2025. A Class II recall means that the affected drug could cause temporary or medically reversible side effects, but the risk of serious health consequences is low.
Zydus Recalls Nelarabine Injection
Zydus Pharmaceuticals (USA) Inc has also recalled its Nelarabine Injection, a drug used in the treatment of certain cancers. The recall covers 36,978 vials of Nelarabine Injection (250mg/50mL, 5mg/mL) due to failed impurities and degradation specifications. The company also recalled an additional 1,893 vials of the same drug.
The recall was initiated on February 13, 2025, as a Class II nationwide recall, meaning that while the issues may cause mild to moderate health concerns, the risk of serious harm is considered remote.
Impact on US Pharmaceutical Market
Indian pharmaceutical companies play a crucial role in the US drug market, supplying a large share of generic medicines. In 2022, four out of ten prescriptions in the US were filled with medicines supplied by Indian drug manufacturers.
According to industry estimates, Indian pharmaceutical companies provided $219 billion in savings to the US healthcare system in 2022 alone. Between 2013 and 2022, medicines from India helped save $1.3 trillion in healthcare costs. Experts predict that Indian generics will save another $1.3 trillion over the next five years.
Ensuring Drug Safety and Compliance
The recalls by Sun Pharma and Zydus highlight the strict regulatory standards enforced by the USFDA. While recalls are not uncommon in the pharmaceutical industry, they emphasize the importance of maintaining high-quality standards in drug manufacturing.
Both companies are expected to address the quality concerns and work towards resolving manufacturing issues to ensure patient safety and continued trust in Indian generic medicines worldwide.
