Amerisource Health Services recalls 60mg Duloxetine capsules due to potential N-nitroso impurity above safety limits. This may pose health risks. Consumers should contact the manufacturer for details.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Amerisource Health Services is recalling 60mg Duloxetine Delayed-Release Capsules because they contain an impurity (N-nitroso-duloxetine) that exceeds safe levels. This could potentially cause health risks, though the exact risk level isn't specified in the recall.
The capsules contain N-nitroso-duloxetine impurities above the recommended safety limit. This impurity could potentially cause health issues, though the exact risk level isn't clearly stated in the recall.
People who have the specific 60mg Duloxetine capsules with NDC 68001-415-04 and lot number DT6023061B are affected. Those taking this medication for depression or nerve pain may be at risk.
Check for the product name 'Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles' manufactured by Aurobindo Pharma Limited. Look for the lot number DT6023061B and expiration date 01/31/2025 on the packaging.
Identify the lot number DT6023061B and expiration date 01/31/2025 on the packaging.
The recall states there is a potential risk due to impurities, but the exact health risk level isn't specified in the official notice.
The recall does not provide specific action steps for consumers, only product identification details.
The recall mentions a potential health risk but does not specify if it can cause serious injury or death.
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-0157-2025 — Amerisource Health Services Amerisource Health Services Hello, I own a Amerisource Health Services that is covered by recall D-0157-2025 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.
