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

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-04-14 08:00 GMT | Update On 2025-04-14 08:00 GMT

Sun Pharma, Zydus, and Glenmark are recalling various products in the US market due to manufacturing-related concerns, the US health regulator stated.

In the latest Enforcement Report, USFDA stated that Mumbai-based Glenmark is recalling more than 25 products in the US over Current Good Manufacturing Practice (CGMP) deviations.

New Jersey-based Glenmark Pharmaceuticals Inc is recalling affected lots of medications like Propafenone Hydrochloride extended-release capsules and Solifenacin Succinate Tablets in America, the USFDA said.

It is also recalling products like Voriconazole Tablets, Lacosamide Tablets, Frovatriptan Succinate Tablets and Rufinamide Tablets. The company initiated the Class II recall on March 13 this year.

As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.

According to PTI, A US-based subsidiary of Sun Pharma is recalling around 13,700 bottles of Gabapentin capsules, a medication used to treat and prevent seizures in people with epilepsy.

New Jersey-based Sun Pharmaceutical Industries Inc is recalling the affected lot due to 'Cross Contamination', the USFDA said. The company initiated the Class III recall on March 4, 2025.

The US health regulator said

Zydus Pharmaceuticals (USA) Inc is recalling 3,144 bottles of chlorproMAZINE Hydrochloride Tablets, USP 10 mg, a medication used to treat mental health conditions, like schizophrenia and bipolar disorder.

The drug firm is recalling the affected lot due to CGMP deviations, the USFDA said.

There was "presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit," it added. The company initiated the Class II recall on April 3, 2025.

Article Source : with inputs

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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

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