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

Indian drugmakers Glenmark Pharmaceuticals, Sun Pharmaceutical Industries, and Zydus are recalling several medicines from the US market due to manufacturing-related problems, according to a latest report by the US Food and Drug Administration (FDA).

Mumbai-based Glenmark is recalling over 25 products from the US due to deviations from current good manufacturing practices (CGMP).

Its US arm, Glenmark Pharmaceuticals Inc., based in New Jersey, is pulling back several medicines, including Propafenone Hydrochloride extended-release capsules and Solifenacin Succinate Tablets.

Other recalled medicines include Voriconazole Tablets, Lacosamide Tablets, Frovatriptan Succinate Tablets, and Rufinamide Tablets. The company began this Class II recall on 13 March 2025.

According to the USFDA, a Class II recall is issued when using the product may cause temporary or medically reversible health issues. However, the chances of serious health problems are low.

Another Indian pharma company, Sun Pharmaceutical Industries, is also recalling a product in the US. Its US-based unit, Sun Pharmaceutical Industries Inc., has recalled around 13,700 bottles of Gabapentin capsules.

These capsules are used to treat and prevent seizures in people with epilepsy. The recall was initiated due to concerns of ‘cross-contamination.’

This Class III recall started on 4 March 2025. A Class III recall is considered the least serious and is made when the use of a product is not likely to cause harm.

Meanwhile, Zydus Pharmaceuticals (USA) Inc., a subsidiary of Zydus, is recalling 3,144 bottles of Chlorpromazine Hydrochloride Tablets.

These tablets are used for treating mental health conditions such as schizophrenia and bipolar disorder.

The USFDA said the recall was due to the presence of an impurity, N-Nitroso-Desmethyl Chlorpromazine, found above the acceptable limit. The company began this Class II recall on 3 April.

The USFDA regularly monitors the safety and quality of medicines sold in the US and ensures that drugmakers follow strict manufacturing standards.