Glenmark recalls 60mg Atomoxetine Capsules due to N-Nitroso impurity exceeding FDA limits. Affected lots manufactured in Memphis, TN. Consumers should contact pharmacy for replacement.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark is recalling 60mg Atomoxetine capsules because they contain an impurity that exceeds FDA safety limits. This could pose a health risk to people taking the medication.
The capsules contain N-Nitroso Atomoxetine impurities above the FDA's safety threshold. This impurity could potentially cause health issues, though the exact risk level isn't specified in the recall notice.
People prescribed Atomoxetine by a doctor who received the recalled capsules from the specific lots listed. Those with the medication may be at risk if they take it without knowing the impurity levels.
Check for the product name 'Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles' with lot numbers 19234630 (expires 10/2025) or 19240529 (expires 1/2026).
Look for the lot numbers 19234630 or 19240529 on the packaging.
The recall states the impurity levels exceed FDA limits, but the exact health risk isn't specified. Consult your doctor for advice.
Check for the lot numbers 19234630 (expires 10/2025) or 19240529 (expires 1/2026) on the packaging.
The recall does not specify a remedy, so contact your pharmacy for guidance.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0242-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0242-2025 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.
