Sun Pharma, Zydus Withdraw Drugs in US Over Quality Red Flags

Two leading Indian pharmaceutical companies, Sun Pharmaceutical Industries and Zydus Pharmaceuticals, are recalling certain products from the US market due to manufacturing issues. The recalls were disclosed in the latest Enforcement Report issued by the US Food and Drug Administration (USFDA).

Sun Pharmaceutical Industries, Inc., headquartered in New Jersey, has initiated a recall of 9,840 bottles of Morphine Sulfate extended-release tablets. The recall was prompted by a failure to meet dissolution specifications, which indicates that the medication may not dissolve properly in the body, potentially affecting its effectiveness. This recall has been classified as a Class II recall, which suggests that the use of or exposure to the product could cause temporary or medically reversible adverse health consequences, but the likelihood of serious harm is relatively low. The company began the nationwide recall in the US on February 6, 2025.

Meanwhile, Zydus Pharmaceuticals has also recalled certain products, although specific details about the nature of the issues and the products involved have not been fully disclosed. The recalls highlight ongoing quality control challenges faced by pharmaceutical manufacturers, particularly when it comes to meeting stringent regulatory standards set by the USFDA.

These recalls underscore the importance of maintaining strict manufacturing protocols and quality checks to ensure the safety and efficacy of pharmaceutical products in the US market.

Zydus Pharmaceuticals (USA) Inc. has initiated a recall of two lots of Nelarabine Injection, a medication used to treat certain types of cancer, due to quality issues. The recall was detailed in a recent Enforcement Report from the US Food and Drug Administration (USFDA).

According to the USFDA, Zydus is recalling a total of 36,978 vials of Nelarabine Injection, which are packaged in a concentration of 250 mg/50 mL (5 mg/mL). The recall was prompted by the drug’s failure to meet specified standards for impurities and degradation. This suggests that the product may have developed unwanted chemical changes over time, potentially affecting its safety and effectiveness.

In addition to the larger lot, Zydus is also recalling another 1,893 vials of Nelarabine Injection of the same strength. Both recalls have been classified as Class II, indicating that the use of or exposure to the affected products may cause temporary or medically reversible adverse health effects, but the risk of serious harm is considered low.

The recall was officially initiated on February 13, 2025. The action reflects ongoing efforts by the USFDA and pharmaceutical manufacturers to uphold stringent quality and safety standards for medications available in the US market.

A Class II recall is initiated when a product is found to violate established safety or quality standards, but the potential health risks associated with its use are considered relatively low. Specifically, this type of recall applies when the use of the affected product could lead to temporary health issues or adverse effects that are medically treatable and reversible. In such cases, the likelihood of the product causing serious or life-threatening health consequences is minimal. Class II recalls are typically issued as a precautionary measure to prevent further distribution and use of the product while corrective actions are taken to address the underlying issues.