Glenmark Recalls 1.5 Million ADHD Medication Bottles Over Safety Concerns

Glenmark Pharmaceuticals has initiated a recall of approximately 1.5 million bottles of its ADHD medication in the U.S., following findings of safety violations. The U.S. Food and Drug Administration (FDA) announced the recall due to "CGMP Deviations," which refers to violations of current good manufacturing practices.

The recall affects around 1.476 million bottles of Atomoxetine Capsules, available in various strengths ranging from 10 mg to 100 mg. The FDA reported that the recall was prompted by the presence of N-Nitroso Atomoxetine impurity exceeding the recommended limits.

Glenmark Pharmaceuticals Inc., based in New Jersey and a subsidiary of the Mumbai-based company, initiated this Class II recall on January 29, 2025. A Class II recall indicates that exposure to the violative product may lead to temporary or medically reversible adverse health consequences, though the likelihood of serious consequences is considered remote.

ADHD, or Attention Deficit Hyperactivity Disorder, is a prevalent neurodevelopmental disorder, primarily affecting children's ability to focus and control impulses. The recall highlights ongoing concerns regarding drug safety and regulatory compliance in the pharmaceutical industry.