Glenmark recalls 40mg Atomoxetine capsules due to potential N-Nitroso impurity exceeding FDA limits. Affected lots from 19234109 to 19241806. Consumers should contact for details.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark is recalling 40mg Atomoxetine capsules because they contain an impurity (N-Nitroso Atomoxetine) that exceeds FDA safety limits. This could pose a health risk, though the exact danger level isn't specified in the recall notice.
The capsules contain an impurity called N-Nitroso Atomoxetine that exceeds the FDA's recommended safety limit. This impurity could potentially cause health issues, but the exact risk level isn't clearly described in the recall notice.
People who have the specific lot numbers of 40mg Atomoxetine capsules (NDC 68462-268-30) from the listed dates. Those using prescription medication for ADHD or impulse control disorders are most at risk.
Check the lot number on the bottle label: 19234109 (exp. 9/2025), 19234897 (exp. 11/2025), 19240501 (exp. 1/2026), 19241489 (exp. 3/2026), or 19241806 (exp. 4/2026). The product is a prescription-only 40mg capsule bottle with NDC 68462-268-30.
Look for the lot numbers 19234109, 19234897, 19240501, 19241489, or 19241806 on the bottle label.
The recall states the product contains an impurity above FDA limits, but the exact health risk isn't specified. Consumers should check if they have the affected lot numbers.
Check the lot number on the bottle: 19234109 (exp. 9/2025), 19234897 (exp. 11/2025), 19240501 (exp. 1/2026), 19241489 (exp. 3/2026), or 19241806 (exp. 4/2026).
The recall doesn't specify a remedy, so contact Glenmark Pharmaceuticals for further instructions.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0234-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0234-2025 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.
