Glenmark, Sun Pharma, Zydus recall products in US over manufacturing issues

Pharmaceutical companies Glenmark, Sun Pharma, and Zydus are withdrawing products in the US due to manufacturing problems, according to the most recent Enforcement Report from the US Food and Drug Administration (USFDA).

According to the US health authority, Glenmark, based in Mumbai, is recalling more than 25 products from the US market because of deviations in Current Good Manufacturing Practice (CGMP).

Glenmark Pharmaceuticals Inc, located in New Jersey, is recalling certain lots of medications such as Propafenone Hydrochloride extended-release capsules and Solifenacin Succinate Tablets, according to the USFDA. Additionally, it is recalling other products including Voriconazole Tablets, Lacosamide Tablets, Frovatriptan Succinate Tablets, and Rufinamide Tablets. The company launched the Class II recall on March 13 of this year.

According to the USFDA, a Class-II recall is started when the use of, or exposure to, a non-compliant product could result in temporary or medically reversible health effects, or when the chance of serious negative health outcomes is low.

A subsidiary of Sun Pharma located in the US is recalling approximately 13,700 bottles of Gabapentin capsules, a drug utilized for treating and preventing seizures in individuals with epilepsy. The US health authorities stated that Zydus Pharmaceuticals (USA) Inc is pulling back 3,144 bottles of chlorproMAZINE Hydrochloride Tablets, USP 10 mg, a medication aimed at addressing mental health issues such as schizophrenia and bipolar disorder.

The pharmaceutical company is retracting the impacted batch because of CGMP noncompliance, according to the USFDA. It stated that there was “presence of N-Nitroso-Desmethyl Chlorpromazine impurity exceeding the suggested interim limit.” The organization began the Class II recall on April 3, 2025.