Amerisource Health Services recalls 20mg Duloxetine capsules due to potential N-nitroso impurity exceeding safety limits. Affected lots manufactured in India for BluePoint Laboratories.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Amerisource Health Services is recalling 20mg Duloxetine Delayed-Release Capsules because they contain an impurity (N-nitroso-duloxetine) that may exceed safe levels. This could pose a health risk to people taking the medication as prescribed.
The capsules contain N-nitroso-duloxetine impurities above the recommended safety limit. This impurity could potentially cause health issues when taken as directed, though the exact risk level isn't specified in the recall.
People with prescriptions for Duloxetine 20mg capsules who received the recalled lots from BluePoint Laboratories. Those taking the medication for depression or nerve pain are most at risk.
Check if your bottle has the NDC code 68001-413-06 and was manufactured with lots DT2023001A or DT2023009A, expiring January 31, 2025.
Look for the NDC code 68001-413-06 and lot numbers DT2023001A or DT2023009A on the bottle.
The recall is due to CGMP deviations where N-nitroso-duloxetine impurities were found above the recommended safety limit.
Check for the NDC code 68001-413-06 and lot numbers DT2023001A or DT2023009A on the bottle, which expire January 31, 2025.
The recall record does not specify a remedy, so contact your healthcare provider for guidance.
We’ve drafted a message you can send Amerisource Health Services to request your refund or repair — edit it as you like.
Subject: Recall D-0099-2025 — Amerisource Health Services Amerisource Health Services Hello, I own a Amerisource Health Services that is covered by recall D-0099-2025 from Amerisource Health Services. 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.
