Glenmark, Sun Pharma and Zydus are recalling pharmaceutical products in the United States due to manufacturing-related issues, according to the latest Enforcement Report issued by the US Food and Drug Administration (USFDA).
Mumbai-based Glenmark is recalling more than 25 products in the US market owing to deviations from Current Good Manufacturing Practice (CGMP) standards. Glenmark Pharmaceuticals Inc, headquartered in New Jersey, is withdrawing various medications including Propafenone Hydrochloride extended-release capsules and Solifenacin Succinate Tablets, the USFDA stated.
The recall also includes products such as Voriconazole Tablets, Lacosamide Tablets, Frovatriptan Succinate Tablets and Rufinamide Tablets. The company initiated the Class II recall on March 13, 2025.
According to the USFDA, a Class II recall is implemented when use of, or exposure to, a violative product may result in temporary or medically reversible health consequences, or when the probability of serious adverse health outcomes is low.
In a separate case, Sun Pharmaceutical Industries Inc, a New Jersey-based subsidiary of Sun Pharma, is recalling approximately 13,700 bottles of Gabapentin capsules, a drug used to treat and prevent seizures in patients with epilepsy. The recall, classified as Class III, was initiated on March 4, 2025, due to issues related to 'Cross Contamination', the USFDA reported.
Meanwhile, Zydus Pharmaceuticals (USA) Inc is recalling 3,144 bottles of chlorproMAZINE Hydrochloride Tablets, USP 10 mg. The drug is commonly prescribed for mental health conditions such as schizophrenia and bipolar disorder.
The USFDA said the affected lot is being withdrawn due to CGMP deviations and noted the 'presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit'. Zydus initiated the Class II recall on April 3, 2025.
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Glenmark, Sun Pharma, and Zydus have recalled multiple drug products in the US due to manufacturing issues

Glenmark, Sun, Zydus Recall Products in US

Glenmark, Sun Pharma, and Zydus have recalled multiple drug products in the US due to manufacturing issues

April 13, 2025 | 16:22 IST