Glenmark recalls 15L bottles of ADHD medicines in the US
What's the story
Glenmark Pharmaceuticals, a global pharmaceutical giant, is recalling nearly 15 lakh bottles of Atomoxetine capsules from the US market. The recall includes different strengths of this generic drug used for treating Attention Deficit Hyperactivity Disorder (ADHD). The action was confirmed by the US Food and Drug Administration (USFDA) in its latest Enforcement Report.
Recall details
Reason behind the recall
Glenmark Pharmaceuticals Inc, USA, a subsidiary of the Mumbai-based company, is recalling around 14.76 lakh bottles over "CGMP Deviations," USFDA reported. The health regulator also cited "presence of N-Nitroso Atomoxetine impurity above the FDA recommended limit" as another reason for this recall. The New Jersey-based branch of Glenmark Pharmaceuticals is taking this action with respect to products manufactured in India.
Classification
Class II recall initiated by Glenmark
The Class II recall was initiated on January 29, 2025. According to USFDA, a Class II recall is issued when "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." This classification highlights the potential risks of the recalled ADHD medication.