Glenmark, Sun Pharma & Zydus recall multiple drugs in the U.S. due to quality concerns & impurities
In early 2025, the USFDA initiated multi-company recalls of major Indian pharmaceutical companies, namely Glenmark Pharmaceuticals, Sun Pharmaceutical Industries, and Zydus Pharmaceuticals. This was due to manufacturing deviations and quality control issues and brings to light the paramount importance of compliance in the pharmaceutical industry.
Glenmark Pharmaceuticals: Major Recalls Due To CGMP Deviations
Mumbai-based Glenmark Pharmaceuticals has found many faces scrutinizing its recalls of over 25 different drug products registered in the U.S. market. With the recalls attributed to violations of Current Good Manufacturing Practices (CGMP), which in general terms refer to practices in the pharmaceutical industry that are minimally necessary for assuring the quality and safety of products), the issue of Quality and Compliance in the photo has taken center stage; stringency and adherence aren’t paid any mind and it is evident through the drugs which have shown CGMP Deviations.
These included:
Propafenone Hydrochloride Extended-Release Capsules
Solifenacin Succinate Tablets
Voriconazole Tablets
Lacosamide Tablets
Frovatriptan Succinate Tablets
Rufinamide Tablets
These drugs treated a variety of conditions, from cardiac arrhythmias to neurological disorders, and were classified under Class II recalls that might result in temporary adverse effects or medically reversible consequences. All drug recalls were formally dated March 13, 2025.
Glenmark also initiated a separate Class II recall of about 1.48 million bottles of Atomoxetine for generic Attention Deficit Hyperactivity Disorder (ADHD) therapy following the detection of N-nitroso atomoxetine, a probable human carcinogen, above the acceptable limit in the affected batches manufactured at Glenmark’s Goa plant, India.
Sun Pharmaceutical Industries: Recalls Due to Cross-Contamination and Dissolution Failures
Through its U.S. subsidiary in New Jersey, Sun Pharmaceutical Industries commenced a recall for about 13,700 bottles of Gabapentin capsules, indicated mainly for seizures and nerve pain. The recall was a Class III one due to possible cross-contamination, i.e., unwanted substances possibly being included in the product. It suggests that use is not likely to cause adverse health consequences. The recall started on March 4, 2025.
In another instance, on February 6, 2025, Sun Pharma recalled 9,840 bottles of Morphine Sulfate Extended-Release Tablets, resulting in a Class II recall due to the tablets failing to comply with dissolution specifications, which may affect the efficacy and safety of the drug.
Zydus Pharmaceuticals: Recalls Triggered by Impurity Concerns
Zydus Pharmaceuticals (USA) Inc., a subsidiary of Indian multinational Zydus, is recalling 3,144 bottles of Chlorpromazine Hydrochloride Tablets used for treating psychiatric disorders, such as schizophrenia and bipolar disorder. The Class II recall was initiated due to the presence of N-Nitroso-Desmethyl Chlorpromazine, an impurity detected at higher-than-acceptable levels. The recall started on April 3, 2025.
In prior recalls, Zydus also pulled 36,978 vials of Nelarabine Injection, a drug used in chemotherapy, for impurity and degradation specification failures. This recall was classified as Class II and was initiated in February 2025.
Implications for the Indian Pharmaceutical Industry
The recalls draw attention to the woes of Indian pharmaceutical companies maintaining adherence to rigorous standards for quality, especially when providing to regulated markets like the United States. US Food and Drug Administration (USFDA) compliance remains one priority that builds trust and ensures market share, as the US is heavily dependent on generic drugs from India with Indian companies contributing a substantial bulk of medicines consumed here.
Presence of impurities such as nitrosamines and issues with cross-contamination or failing dissolution tests not only endanger consumers’ health but also are straws that threaten to break the camel’s back for these companies’ reputation and economic viability. Such incidences call for robust quality assurance systems along with regular audits.
Regulatory Oversight and Future Outlook
The USFDA, in its active pursuit of monitoring and enforcing quality standards, reminds us of the significance of compliance in the pharmaceutical industry. Thus, companies should invest in modern manufacturing technologies, employee training, and complete quality management systems to satisfy regulatory expectations.
From now on, Indian pharmaceutical firms can look forward to stringent scrutiny; hence, their manufacturing practices will be revised. Strengthening measures against substandard quality control will safeguard patient safety and further aid growth for the international market.
To sum up, the recent product recalls of Glenmark, Zydus, and Sun Pharmaceutical industries in the U.S. market reiterate the vital importance of rigorous compliance to manufacture and quality control standards. These challenges need to be taken up by Indian pharmaceutical companies as they build on their global reputation and continue to take care of public health around the world.
