Glenmark, Sun Pharma, Zydus Announce US Medicine Recalls Due to Manufacturing Issues
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Synopsis
Indian drugmakers Glenmark, Sun Pharma, and Zydus are recalling various medicines from the US market due to manufacturing concerns. Glenmark is recalling over 25 products, while Sun Pharma and Zydus are addressing specific issues in their drugs. The FDA oversees these recalls to ensure compliance with safety standards.
Key Takeaways
- Glenmark recalls over 25 products from the US.
- Sun Pharma recalls 13,700 Gabapentin capsules.
- Zydus recalls Chlorpromazine Hydrochloride Tablets.
- Class II and III recalls involve different health risk levels.
- The USFDA monitors drug safety and manufacturing standards.
New Delhi, April 13 (NationPress) Indian pharmaceutical companies Glenmark Pharmaceuticals, Sun Pharmaceutical Industries, and Zydus are initiating recalls for multiple medications in the US market attributed to manufacturing-related complications, as reported by the US Food and Drug Administration (FDA).
The Mumbai-based Glenmark is recalling more than 25 products from the US due to violations of current good manufacturing practices (CGMP).
Its US branch, Glenmark Pharmaceuticals Inc. located in New Jersey, is withdrawing several medications such as Propafenone Hydrochloride extended-release capsules and Solifenacin Succinate Tablets.
Other medications included in the recall are Voriconazole Tablets, Lacosamide Tablets, Frovatriptan Succinate Tablets, and Rufinamide Tablets. This Class II recall commenced on March 13 of this year.
The USFDA defines a Class II recall as one that suggests using the product may lead to temporary or medically reversible health issues, although serious health risks are minimal.
Additionally, Sun Pharmaceutical Industries is also recalling a product in the US. Its US subsidiary, Sun Pharmaceutical Industries Inc., has recalled approximately 13,700 bottles of Gabapentin capsules.
These capsules are prescribed to manage and prevent seizures in individuals with epilepsy. The recall was prompted by concerns over cross-contamination.
This Class III recall began on March 4, 2025, and is classified as the least serious, indicating that the product's use is unlikely to result in harm.
Simultaneously, Zydus Pharmaceuticals (USA) Inc., a subsidiary of Zydus, is recalling 3,144 bottles of Chlorpromazine Hydrochloride Tablets.
These tablets are utilized to treat various mental health disorders such as schizophrenia and bipolar disorder.
The USFDA stated that the recall was due to the detection of an impurity, N-Nitroso-Desmethyl Chlorpromazine, present beyond acceptable limits. The company initiated this Class II recall on April 3.
The USFDA consistently oversees the safety and quality of medicines available in the US and ensures compliance with stringent manufacturing regulations.
