Glenmark Pharmaceuticals recalls 40mg Atomoxetine capsules due to N-Nitroso impurity exceeding FDA limits. Affected lots manufactured in Memphis, TN. Stop using immediately.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals is recalling 40mg Atomoxetine capsules that contain an impurity above FDA safety limits. This could pose a health risk, so affected users should stop using the product immediately.
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 regularly.
People with prescriptions for Atomoxetine capsules from the recalled lots. Those who have the specific lot numbers listed in the recall are most at risk.
Check the product label for the lot numbers: 19232540, 19232524, 19232553 (expiring 5/2025), 19240510 (expiring 1/2026), 19241489 (expiring 3/2026), 19243905 and 19243935 (expiring 9/2026).
Immediately stop using the recalled Atomoxetine capsules if you have them.
The capsules contain N-Nitroso Atomoxetine impurities above the FDA recommended limit.
Lot numbers 19232540, 19232524, 19232553 (expiring 5/2025), 19240510 (expiring 1/2026), 19241489 (expiring 3/2026), 19243905 and 19243935 (expiring 9/2026).
Check the product label for the lot numbers listed in the recall notice.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0241-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0241-2025 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.