Amerisource Health Services LLC recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma
Amerisource Health Services recalls 60mg Duloxetine capsules due to potential N-nitroso-duloxetine impurity exceeding safety limits. This may pose health risks with long-term use. Contact for return instructions.
Lower-risk recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Contact the company & request your remedy
What happened, in plain English
Amerisource Health Services is recalling 60mg Duloxetine Delayed-Release Capsules because they contain an impurity (N-nitroso-duloxetine) that exceeds safe levels. This could lead to health risks with long-term use of the product. Read more at govinfonow.com/recall/32427-duloxetine-capsules-recall-n-nitroso-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32427-duloxetine-capsules-recall-n-nitroso-impurity-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0101-2025
Cite this page
“Duloxetine Capsules Recall: N-nitroso Impurity Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32427-duloxetine-capsules-recall-n-nitroso-impurity-risk. Based on FDA recall #D-0101-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0101-2025%22&limit=1).
Why it’s dangerous
The capsules contain N-nitroso-duloxetine impurities above the recommended safety limit. This impurity could potentially cause health issues with long-term use of the medication.
Who’s affected
People who have the specific lot numbers of Duloxetine capsules from Aurobindo Pharma. Those with prescription for depression treatment are most at risk.
How to tell if you have this one
Check the product label for the lot numbers: DT6022159A, DT6022167A, DT6022168A (expiring 11/30/2024), DT6023034A (12/31/2024), and other specified lots with their expiration dates.
- Brand
Amerisource Health Services- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
PA, OH, PR
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0099-2025 | Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06; Lots: DT2023001A, DT2023009A, exp date Jan 31, 2025 | 37,916 bottles |
| D-0100-2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories; a) 30 count; Lot, expiry: DT3023019B, DT3023020A, exp 01/31/2025 b) 1000 count; Lot, expiry: DTB23098A, exp 08/31/2025 | 23,490 bottles |
| D-0101-2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08; Lot, expiry: DT6022159A, DT6022167A, DT6022168A, exp 11/30/2024; Lot DT6023034A, 12/31/2024; Lots DT6023050A, DT6023051A, DT6023063A, DT6023067A, exp 01/31/2025; Lots DT6023073A, DT6023072A, exp 02/28/2025 | 8,561 bottles |
What to do — step by step
Check Product Label
Look for the lot numbers and expiration dates listed in the product label to determine if your capsules are affected.
Questions people ask
Is this product safe to use?
The product contains an impurity that exceeds safety limits, so it is not recommended for use. Contact the manufacturer for return instructions.
What should I do if I have the recalled product?
Check the product label for the lot numbers and expiration dates to see if your capsules are affected. If they are, contact Amerisource Health Services for return instructions.
How can I get a refund or replacement?
The official recall notice does not specify refund or replacement options. Contact Amerisource Health Services directly for assistance.
Contact Amerisource Health Services
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-0101-2025 — Amerisource Health Services Amerisource Health Services Hello, I own a Amerisource Health Services that is covered by recall D-0101-2025 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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Where this comes from
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.
- Official source: FDA Recall #D-0101-2025 (November 14, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0101-2025 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.