Glenmark recalls 100mg Atomoxetine capsules due to N-Nitroso impurity exceeding FDA limits. Affected lots manufactured in India with specific expiration dates. Stop using immediately if you have these capsules.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark is recalling 100mg Atomoxetine capsules that contain an impurity above FDA safety limits. This could pose a health risk if taken as directed. Affected products have specific lot numbers and expiration dates.
The capsules contain N-Nitroso Atomoxetine impurities at levels above the FDA's recommended safety limit. This impurity could potentially cause health issues when taken as directed, though the exact risk level isn't specified in the recall.
People with prescriptions for Atomoxetine capsules from Glenmark's recalled lots. Those using the medication for ADHD or impulse control disorders are most at risk.
Check for lot numbers 19234955, 19234956 (expiring 11/2025), 19240971 (expiring 2/2026), or 19241864 (expiring 4/2026) on the product label. The capsules are 100mg, 30-count bottles prescribed by a doctor.
If you have the recalled capsules, stop using them right away and contact your doctor.
The capsules contain N-Nitroso Atomoxetine impurities above the FDA's recommended safety limit.
Stop using them immediately and contact your doctor for guidance.
Yes, check for lot numbers 19234955, 19234956 (expiring 11/2025), 19240971 (expiring 2/2026), or 19241864 (expiring 4/2026).
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0237-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0237-2025 from Glenmark. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
