Glenmark recalls 18mg Atomoxetine Capsules due to N-Nitroso impurity exceeding FDA limits. Affected lots manufactured in India with specific expiration dates. Consumers should contact for details.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark is recalling 18mg Atomoxetine capsules because they contain an impurity that exceeds FDA safety limits. This could pose a health risk if taken by people who need the medication.
The capsules contain N-Nitroso Atomoxetine impurities above the FDA's recommended limit. This impurity could potentially cause health issues, though the risk is not severe enough to cause immediate harm.
People with prescriptions for Atomoxetine who own the recalled capsules. Those with specific lot numbers and expiration dates listed are most at risk.
Check for the product name 'Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles' with lot numbers 19233756 (exp. 8/2025), 19235111 (exp. 11/2025), 19242167 (exp. 5/2026), or 19242180 (exp. 5/2026).
Look for the lot numbers and expiration dates listed in the recall notice to confirm if your capsules are affected.
The capsules contain N-Nitroso Atomoxetine impurities above the FDA's recommended limit, which could pose a health risk.
The recall notice does not specify a remedy, so contact Glenmark Pharmaceuticals for further instructions.
Yes, the affected lots are 19233756 (exp. 8/2025), 19235111 (exp. 11/2025), 19242167 (exp. 5/2026), and 19242180 (exp. 5/2026).
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0232-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0232-2025 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.
