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Glenmark has recalled 1.5 million bottles of Atomoxetine Capsules in the US due to impurity concerns. The Class II recall was initiated on January 29. The affected medication is used for ADHD treatment. Glenmark share price may face market fluctuations following the recall.
Glenmark Pharmaceuticals Inc., USA, a subsidiary of the Mumbai-based pharmaceutical company, has recalled 1.5 million bottles of Atomoxetine Capsules in the US market due to quality concerns. The recall, classified as Class II by the US Food and Drug Administration (USFDA), was initiated on January 29, 2025. The reason behind the recall is the presence of N-Nitroso Atomoxetine impurity above the FDA's recommended limit, which could pose health risks. The affected medication is used for treating attention deficit hyperactivity disorder (ADHD) and is available in multiple strengths ranging from 10 mg to 100 mg.
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Total Recall: 1.5 million bottles of Atomoxetine Capsules.
Reason for Recall: High levels of N-Nitroso Atomoxetine impurity.
Regulatory Action: Classified as a Class II recall by the USFDA.
Product Strengths Affected: 10 mg to 100 mg.
Initiation Date: January 29, 2025.
Market Impact: Glenmark share price may react to the development.
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The USFDA defines Class II recalls as situations where the use of a violative product may cause temporary or medically reversible adverse health consequences, with a remote probability of serious harm. Atomoxetine is commonly prescribed for ADHD, a neurodevelopmental disorder that affects focus, impulse control, and activity levels. The impurity found in the recalled batches may raise safety concerns, leading to tighter regulatory scrutiny on Glenmark's quality control processes.
Parameter | Details |
Company | Glenmark Pharmaceuticals Inc., USA |
Product Name | Atomoxetine Capsules |
Total Bottles Recalled | 1.5 million (14.76 lakh) |
Strengths Affected | 10 mg to 100 mg |
Recall Reason | Presence of N-Nitroso Atomoxetine impurity above FDA limits |
Recall Classification | Class II (Potential for temporary or reversible adverse effects) |
Initiation Date | January 29, 2025 |
Glenmark’s recall of ADHD medication in the US highlights regulatory challenges in maintaining quality control in pharmaceutical exports. The financial and reputational impact remains to be seen, but market analysts will closely monitor Glenmark share price in response to the recall. While the company addresses the issue, investors and stakeholders will await updates on how Glenmark plans to manage regulatory compliance moving forward.
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