Glenmark Pharmaceuticals recalls 25mg Atomoxetine Capsules due to N-Nitroso impurity exceeding FDA limits. Affected lots from 19233792 to 19243887 with expiration dates through 9/2026.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark is recalling 25mg Atomoxetine Capsules that may contain N-Nitroso impurity above FDA safety limits. This impurity could pose health risks with long-term use, though the recall does not specify immediate danger.
The capsules contain N-Nitroso Atomoxetine impurity levels above the FDA's recommended safety limit. This impurity may cause health issues with prolonged use, but the recall does not indicate immediate harm.
Patients prescribed Atomoxetine for ADHD or other conditions who have the specific lot numbers listed. Those with the capsules from India manufactured by Glenmark are most at risk.
Check the product label for the lot numbers: 19233792, 19233795, 19234258, 19240912, 19241476, 19241477, 19242599, 19243162, 19243163, 19243884, 19243887. The capsules are 25mg, 30-count bottles sold by prescription in the US.
Look for lot numbers 19233792 through 19243887 on the capsule bottle.
The recall states the capsules may contain N-Nitroso impurity above FDA limits, but does not specify immediate danger. Long-term use could pose health risks.
Check the product label for lot numbers 19233792 to 19243887, which are listed in the recall notice.
The recall does not specify a remedy, so contact your healthcare provider for advice on whether to stop using the product.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0233-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0233-2025 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.
