Glenmark Pharmaceuticals recalls 18mg 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 18mg Atomoxetine Capsules because they contain an impurity (N-Nitroso Atomoxetine) that exceeds the FDA's safety limits. This could pose a health risk, though the specific danger isn't detailed in the recall notice.
The recall is due to the presence of N-Nitroso Atomoxetine impurity in the product, which 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 who have the specific 18mg Atomoxetine Capsules with the listed lot numbers and expiration dates are affected. Those using prescription ADHD medication may be at risk.
Check for the product name 'Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles' with the lot numbers listed: 19233228, 19233227, 19233757, 19234229, 19235090, 19241471, 19242180. The expiration dates range from July 2025 to May 2026.
Identify the lot number and expiration date on the product label to confirm if it's affected.
The recall states the product contains an impurity above FDA limits, but the specific health risk isn't detailed. Consult your healthcare provider for advice.
The recall does not specify a remedy, so contact Glenmark Pharmaceuticals for further instructions.
Check the lot number and expiration date on the product label against the listed numbers: 19233228, 19233227, 19233757, 19234229, 19235090, 19241471, 19242180.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0239-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0239-2025 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.
