Amerisource Health Services recalls Duloxetine 30mg and 1000-count capsules due to potential impurity levels exceeding safety limits. 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 two types of Duloxetine Delayed-Release Capsules (30-count and 1000-count) because they contain an impurity that could be unsafe. This recall is for prescription-only medication that was manufactured in India and distributed through BluePoint Laboratories.
The capsules contain N-nitroso-duloxetine impurities at levels above the recommended safety threshold. This impurity could potentially cause health issues, though the exact risk level is not specified in the recall notice.
Prescription patients who have received the recalled Duloxetine capsules from BluePoint Laboratories. Those with the specific lot numbers and expiration dates listed are most at risk.
Check for the product name 'Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only'. Look for the NDC codes 68001-414-04 (30-count) or 68001-414-08 (1000-count). The lot numbers and expiration dates are also listed in the recall.
Reach out to Amerisource Health Services for specific instructions on how to return or dispose of the recalled capsules.
The recall states there is a potential impurity risk, but the exact health impact is not specified. The manufacturer recommends contacting them for details.
The affected lot numbers are DT3023019B, DT3023020A (for 30-count) and DTB23098A (for 1000-count).
Check the NDC codes on the product label: 68001-414-04 for 30-count or 68001-414-08 for 1000-count.
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-0100-2025 — Amerisource Health Services Amerisource Health Services Hello, I own a Amerisource Health Services that is covered by recall D-0100-2025 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.
