Glenmark US arm recalls 15 lakh bottles of ADHD medication in US

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-03-03T13:10:47+05:30 | Updated On 3 March 2025 5:48 PM IST

New Delhi: Glenmark Pharmaceuticals Inc, USA, an arm of the Mumbai-based Glenmark Pharmaceuticals, is recalling around 14.76 lakh bottles of Atomoxetine Capsules in multiple strengths in the US market.

The medication is used for the treatment of attention deficit hyperactivity disorder.

The company is recalling the affected lot due to "CGMP Deviations", the US Food and Drug Administration (USFDA) said in its latest Enforcement Report.

As per PTI report, USFDA added, "The recall is due to "presence of N-Nitroso Atomoxetine impurity above the FDA recommended limit."

New Jersey-based Glenmark Pharmaceuticals Inc, USA is recalling the made-in-India product in strengths ranging from 10 mg to 100 mg, USFDA stated.

The company initiated the Class II recall on January 29 this year.

As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

ADHD is a neurodevelopmental disorder that affects a person's ability to focus, control impulses, and regulate their activity levels.

It is one of the most common mental disorders affecting children.

Glenmark Pharmaceuticals Ltd. is a research-led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 11 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries. Scrip 100 positions Glenmark amongst the Top 100 biopharmaceutical companies ranked by Pharmaceutical Sales in 2023; while Generics Bulletin places it in the Top 50 Generics and biosimilar companies ranked by sales in 2024. The organization has impacted over 3.3 million lives over the last decade through its CSR interventions.

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Source : with inputs

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

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751