Glenmark recalls 10mg Atomoxetine capsules due to N-Nitroso impurity exceeding FDA limits. Affected lots from 19232368 to 19243146. Stop using and contact for details.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark is recalling 10mg Atomoxetine capsules that contain an impurity above FDA safety limits. This could pose a health risk if taken as directed.
The capsules contain N-Nitroso Atomoxetine impurities at levels above the FDA's recommended limit. This impurity could potentially cause health issues if taken as directed.
Prescription users of Glenmark's 10mg Atomoxetine capsules. Those with the specific lot numbers listed are most at risk.
Check the lot number on the bottle label. Affected lots include 19232368 (expires 5/2025), 19235088 (expires 11/2025), 19241447 (expires 3/2026), and 19243146 (expires 7/2026).
Look for the lot number on the bottle label to determine if it is affected.
If the lot number matches the affected ones, stop using the capsules immediately.
The capsules contain N-Nitroso Atomoxetine impurities above the FDA recommended limit.
Affected lot numbers are 19232368 (expires 5/2025), 19235088 (expires 11/2025), 19241447 (expires 3/2026), and 19243146 (expires 7/2026).
Check the lot number on the bottle label. If it matches the affected lots listed, the product is recalled.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0231-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0231-2025 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.
