Glenmark recalls 80mg Atomoxetine Capsules due to N-Nitroso impurity exceeding FDA limits. Affected lots from 19234153 to 19244014 with specific expiration dates. No remedy stated in recall notice.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark is recalling 80mg Atomoxetine capsules that may contain an impurity exceeding FDA safety limits. This could pose a health risk, though the recall does not specify a remedy.
The capsules contain N-Nitroso Atomoxetine impurities above the FDA's recommended limit. This impurity could potentially cause health issues, though the exact risk level is not specified in the recall.
Prescription users of Atomoxetine capsules in the US. Those with the specific lot numbers and expiration dates listed are most at risk.
Check the lot number on the capsule bottle label. Affected lots include 19234153 (exp. 9/2025), 19234900, 19234929 (exp. 11/2025), and others with specific expiration dates listed in the recall.
Identify the lot number and expiration date on the capsule bottle label to determine if it is affected.
The recall notice does not state any remedy or action required.
The recall mentions N-Nitroso Atomoxetine impurity exceeding FDA recommended limits.
Affected lots include 19234153 (exp. 9/2025), 19234900, 19234929 (exp. 11/2025), 19240936, 19240942 (exp. 2/2026), and others with specific expiration dates listed in the recall.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0236-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0236-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
