MedCentralNearly 1.5 Million Bottles of Glenmark’s ADHD Drug Atomoxetine Recalled

The nationwide recall of 1.48 million bottles of generic atomoxetine by Glenmark Pharmaceuticals represents a significant medication safety event affecting ADHD treatment availability. This Class II recall was initiated due to unacceptable levels of N-nitroso atomoxetine, a potential carcinogen, according to FDA standards.

Key Clinical Considerations

• Medication substitution needs: Patients currently taking recalled atomoxetine lots will require immediate therapeutic alternatives, potentially increasing demand for other ADHD medications during an ongoing stimulant shortage.
• Carcinogen exposure risk: Although the FDA classified this as Class II (temporary or medically reversible consequences), long-term N-nitroso compound exposure risks must be discussed with affected patients.
• Multiple dosage strengths affected: Recalled products span 10mg to 100mg strengths, potentially impacting pediatric, adolescent, and adult ADHD patients across various treatment regimens.
• Market impact: With brand-name Strattera discontinued (end of 2023), this recall significantly reduces available non-stimulant ADHD medication options.
• Manufacturer quality pattern: This recall represents Glenmark’s seventh major recall since 2022, suggesting potential systemic quality control issues affecting multiple medication classes.

Clinical Practice Impact

• Patient Communication: Verify patient medication against recalled lot numbers; discuss continuation risks versus abrupt discontinuation risks; explain N-nitroso compound exposure context within therapeutic benefit framework.
• Practice Integration: Implement systematic patient identification protocol for those using recalled lots; prepare standing orders for therapeutic alternatives; develop pharmacy coordination plan for medication switches.
• Risk Management: Document all patient notifications about recall exposure; consider limited follow-up monitoring for those with significant exposure to recalled lots; assess practice liability for continued prescribing.
• Action Items: Contact affected patients immediately; coordinate with dispensing pharmacies to identify exposed patients; prepare alternative prescription templates; document all patient communication about recall.

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