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Glenmark Recalls 1.5 Million ADHD Medication Bottles in US: USFDA

Synopsis:

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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GLENMARK PHARMACEUTICALS

Trade

1381.2-3.20 (-0.23 %)

Updated - 30 April 2025
1406.60day high
DAY HIGH
1372.00day low
DAY LOW
694501
VOLUME (BSE)

Key Takeaways:

  • 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.

Also read: Indian Overseas Bank Faces ₹699.5 Crore GST Demand, Plans Legal Challenge

Implications of the Recall

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.

Details of the Recall

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.

Also read: NLC India Wins 200 MW Wind Power Project from SJVN at Rs 3

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