Glenmark recalls 60mg Atomoxetine capsules due to N-Nitroso impurity exceeding FDA limits. Rx-only product with specific lot numbers and expiration dates.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark is recalling 60mg Atomoxetine capsules (30-count bottles) because they contain an impurity that exceeds FDA safety limits. This could pose a health risk to patients using the medication.
The capsules contain N-Nitroso Atomoxetine impurities above the FDA's recommended safety limit. This impurity could potentially cause health issues, though the exact risk level is not specified in the recall.
Patients prescribed Atomoxetine capsules by a doctor. Those with the specific lot numbers listed in the recall are most at risk.
Check for the product name 'Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles' with lot numbers 19234630 (exp. 10/2025) or 19240528/19240529 (exp. 1/2026).
Verify the lot number and expiration date on the capsule bottle to determine if it's in the recall range.
The recall states the product contains an impurity above FDA limits, but the exact health risk is not specified. Consult your doctor for personalized advice.
The recall does not provide specific action steps. Check the product details to see if it's in the recall range and contact your doctor for guidance.
The recall does not mention a replacement or remedy. Contact your doctor for advice on next steps.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0235-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0235-2025 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.
