Mon Mar 03 16:38:58 UTC 2025: ## Major Recall of ADHD Medication: Glenmark Pharmaceuticals Recalls 1.5 Million Bottles

**New Jersey, USA –** Glenmark Pharmaceuticals Inc., the US subsidiary of the India-based global pharmaceutical company, is recalling approximately 1.5 million bottles of its generic atomoxetine capsules, a medication used to treat Attention Deficit Hyperactivity Disorder (ADHD). The recall, classified as Class II by the U.S. Food and Drug Administration (FDA), is due to the presence of N-Nitroso Atomoxetine impurity above the FDA’s acceptable limit. This impurity was discovered in batches manufactured in India and distributed across various strengths (10mg to 100mg).

The FDA’s Enforcement Report cites Current Good Manufacturing Process (CGMP) deviations as the reason for the recall. While the FDA states the risk of serious adverse health effects is considered remote, a Class II recall is initiated when a product may cause temporary or reversible adverse health consequences.

Atomoxetine is a crucial medication for managing ADHD, a neurodevelopmental disorder affecting millions, particularly children. ADHD symptoms include inattention, hyperactivity, and impulsivity, significantly impacting daily life, relationships, and academic/professional performance.

Glenmark Pharmaceuticals has initiated the recall to ensure patient safety. Consumers who have purchased the affected batches are urged to contact their pharmacist or healthcare provider for further instructions. The specific lot numbers subject to the recall are not included in this report. Consumers should check the FDA website for detailed information.

**Disclaimer:** *This news report provides information based on publicly available data. Consult a healthcare professional for any health concerns.*

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