Glenmark Pharmaceuticals recalls 80mg Atomoxetine capsules due to 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 80mg Atomoxetine capsules that contain an impurity above FDA safety limits. This could pose a health risk if taken by people who need the medication.
The capsules contain N-Nitroso Atomoxetine impurity levels above the FDA's recommended safety limit. This impurity could potentially cause health issues if the medication is taken as prescribed.
People with prescriptions for Atomoxetine who received the recalled lots from the listed manufacturers. Those with the specific lot numbers and expiration dates mentioned are most at risk.
Check for the product name 'Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles' with the specific lot numbers: 19233234, 19233253 (exp. 7/2025), 19234154 (exp. 9/2025), 19243185 (exp. 7/2026), 19243951, 19243974 (exp. 9/2026).
Look for the specific lot numbers and expiration dates listed in the recall notice to confirm if your product is affected.
The recall notice states the product contains an impurity above FDA limits, so it is not safe to use as recalled. Consult the official notice for details.
The recall notice does not specify a remedy, so contact Glenmark Pharmaceuticals for further instructions.
The affected lot numbers are 19233234, 19233253 (exp. 7/2025), 19234154 (exp. 9/2025), 19243185 (exp. 7/2026), 19243951, 19243974 (exp. 9/2026).
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0243-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0243-2025 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.
