Glenmark Pharmaceuticals recalls 25mg Atomoxetine Capsules due to N-Nitroso impurity exceeding FDA limits. Affected lots manufactured in Memphis, TN. Consumers should contact for details.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals is recalling 25mg Atomoxetine Capsules that contain an impurity above FDA safety limits. This could pose a health risk to users, especially those taking the medication for ADHD or other conditions.
The capsules contain N-Nitroso Atomoxetine impurities at levels above the FDA's recommended limit. This impurity could potentially cause health issues, though the exact risk is not fully specified in the recall notice.
People who have the specific lot numbers listed in the recall notice are affected. Those using the medication for ADHD or other conditions are most at risk.
Check the lot numbers on the bottle: 19232506, 19232397, 19232415 (expiring 5/2025), 19233791 (expiring 8/2025), and others listed in the recall notice.
Look for the lot numbers listed in the recall notice: 19232506, 19232397, 19232415, 19233791, 19234248, 19240909, 19242598, 19243163, 19243122, 19243884.
The recall notice states the product contains an impurity above FDA limits, but does not specify if it is safe to use. Consumers should check the lot numbers and follow the recall instructions.
The recall notice does not provide a specific remedy or action for affected products. Consumers should check the lot numbers and contact Glenmark Pharmaceuticals for further instructions.
Check the lot numbers on the bottle against the list provided in the recall notice: 19232506, 19232397, 19232415, 19233791, 19234248, 19240909, 19242598, 19243163, 19243122, 19243884.
We’ve drafted a message you can send Glenmark Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0240-2025 — Glenmark Pharmaceuticals Glenmark Pharmaceuticals Hello, I own a Glenmark Pharmaceuticals that is covered by recall D-0240-2025 from Glenmark Pharmaceuticals. 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.