Tejal Somvanshi
Glenmark Pharmaceuticals has recalled approximately 1.5 million bottles of Atomoxetine Capsules from the US market after tests found potentially harmful impurities above FDA-approved limits. The medication, used to treat attention deficit hyperactivity disorder (ADHD), was recalled on January 29, 2025.
The US Food and Drug Administration classified this as a Class II recall, indicating the products may cause “temporary or medically reversible adverse health consequences” with low probability of serious health issues.
According to the FDA’s Enforcement Report, the specific concern is the “presence of N-Nitroso Atomoxetine impurity above the FDA recommended limit.” These compounds, known as nitrosamines, are classified as possible carcinogens when exposure occurs at high levels over extended periods.
“The recall affects multiple strengths of the medication ranging from 10 mg to 100 mg capsules,” states the FDA report. All recalled products were manufactured in India but distributed in the United States through Glenmark Pharmaceuticals Inc. (New Jersey) and Northstar Rx LLC (Tennessee).
Atomoxetine works by increasing attention and decreasing restlessness in people with ADHD. The Mayo Clinic describes it as a medication that helps those who struggle with concentration. It belongs to a class of drugs called selective norepinephrine reuptake inhibitors (SNRIs).
ADHD is one of the most common neurodevelopmental disorders affecting children and adults. People with this condition typically have difficulty focusing, controlling impulses, and regulating activity levels.
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FDA guidance from September 2024 addressed nitrosamine impurities in medications, noting the “need for a risk assessment strategy for the potential presence of nitrosamines in any drug product.” The Cleveland Clinic explains that carcinogens can increase cancer risk.
Patients who believe they have bottles from the affected lots should contact their pharmacy or medical provider for guidance. The recall impacts seven different dosage strengths with expiration dates ranging from May 2025 to September 2026.
The Current Good Manufacturing Practice (CGMP) violations cited in the recall refer to deviations from FDA quality standards that ensure medications are safely produced. Patients should consult with healthcare providers about their options if they believe their medication may be affected by this recall, as untreated ADHD can present challenges in daily functioning.
FAQ
What ADHD medication has been recalled?
Glenmark Pharmaceuticals has recalled about 1.5 million bottles of Atomoxetine Capsules (generic Strattera) in strengths from 10 mg to 100 mg. The recall affects products manufactured for both Glenmark Pharmaceuticals Inc. and Northstar Rx LLC with expiration dates between May 2025 and September 2026.
Why was the medication recalled?
The medication was recalled due to “CGMP Deviations” and specifically the presence of N-Nitroso Atomoxetine impurity above FDA recommended limits. N-Nitroso compounds are considered potential carcinogens (cancer-causing agents) with long-term exposure at high levels.
How do I check if my medication is affected?
Check your prescription bottle for the manufacturer (Glenmark or Northstar Rx), strength (10mg-100mg), and lot number/expiration date. Contact your pharmacy with this information to confirm if your medication is part of the recall.
Should I stop taking my medication immediately?
Contact your pharmacy or medical provider for assistance if you believe you have a bottle of the recalled medication. This is a Class II recall, meaning the risk of immediate serious harm is low, but your healthcare provider can give you proper guidance for your specific situation.
What health risks are associated with this impurity?
The FDA classifies nitrosamines as possible carcinogens that may increase cancer risk. According to the Cleveland Clinic, carcinogens are substances that can increase one’s cancer risk. The Class II recall status indicates temporary or medically reversible health consequences with a low probability of serious health problems.
What should I do if my medication is part of the recall?
Contact your pharmacy or medical provider for assistance if you believe you have a bottle of the recalled medication or if you have any related questions. They can confirm if your specific medication is affected by checking the lot numbers and expiration dates, and provide appropriate next steps.
