Glenmark Pharmaceuticals recalls 10mg Atomoxetine capsules due to potential 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 10mg Atomoxetine capsules because they contain an impurity (N-Nitroso Atomoxetine) that exceeds the FDA's safety limits. This could pose a health risk to users, especially those taking the medication regularly.
The capsules contain an impurity called N-Nitroso Atomoxetine that exceeds the FDA's recommended safety limits. This impurity could potentially cause health issues, though the exact risk level isn't specified in the recall notice.
People with prescriptions for Atomoxetine capsules from the recalled lots are affected. Those taking the medication daily are at higher risk due to potential impurity exposure.
Check the product label for the lot numbers: 19232356 (exp. 5/2025), 19233198 (exp. 7/2025), 19234213, 19234232 (exp. 9/2025), 19241445 (exp. 3/2026), or 19243033, 19243121 (exp. 7/2026). The product is a 10mg capsule bottle with a prescription label.
Look for lot numbers on the label: 19232356, 19233198, 19234213, 19234232, 19241445, 19243033, or 19243121.
The recall mentions N-Nitroso Atomoxetine impurity, but the exact health risk isn't specified in the notice.
Check the product label for lot numbers: 19232356 (exp. 5/2025), 19233198 (exp. 7/2025), 19234213, 19234232 (exp. 9/2025), 19241445 (exp. 3/2026), or 19243033, 19243121 (exp. 7/2026).
The recall does not specify a remedy, so there is no action required beyond checking the lot numbers.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0238-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0238-2025 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.
