Amerisource Health Services LLC recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited,
Amerisource Health Services recalls 30mg Duloxetine capsules (NDC 68001-414-05) manufactured by Aurobindo Pharma due to N-nitroso-duloxetine impurity exceeding safety limits.
Recall notice
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 30mg Duloxetine Delayed-Release Capsules (90-count bottles) made by Aurobindo Pharma because they contain an impurity that could be unsafe. This recall affects prescription-only medication that may pose health risks if taken. Read more at govinfonow.com/recall/32381-amerisource-health-services-recalls-duloxetine-30mg-capsules-due-to-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/32381-amerisource-health-services-recalls-duloxetine-30mg-capsules-due-to-impurity · Updated September 23, 2026 · FDA enforcement record: FDA #D-0156-2025
Cite this page
“Amerisource Health Services recalls Duloxetine 30mg capsules due to impurity risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32381-amerisource-health-services-recalls-duloxetine-30mg-capsules-due-to-impurity. Based on FDA recall #D-0156-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0156-2025%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 when taken as medication, though the exact risk level isn't specified in the recall notice.
Who’s affected
Prescription patients who have received the specific 30mg Duloxetine capsules with NDC 68001-414-05 and lot number DT3023030A. Those with the medication in their current supply are most at risk.
How to tell if you have this one
Check for the product name 'Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles' with NDC code 68001-414-05 and lot number DT3023030A. The medication was manufactured by Aurobindo Pharma in Hyderabad, India.
- Brand
Amerisource Health Services- Category
Drug
All 4 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
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0155-2025 | Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04; Lot DT3023029A Exp 02/28/2025 | 21,262 bottles |
| D-0156-2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05; Lot DT3023030A Exp 2/28/2025 | 13,678 bottles |
| D-0157-2025 | Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04; Lot DT6023061B Exp 01/31/2025 | 20,734 30-count bottles |
| D-0158-2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08; Lots, expiry: Lot DT6022166A, exp 11/30/2024; Lot DT6023071A, exp 2/28/2025 | 1,815 bottles |
What to do — step by step
Check Product Details
Identify the NDC code 68001-414-05 and lot number DT3023030A on the packaging to confirm if the product is recalled.
Questions people ask
Is this medication safe to take?
The recall states there is an impurity above safety limits, but the exact health risk isn't specified. Patients should contact their healthcare provider for guidance.
How can I tell if I have the recalled product?
Look for the NDC code 68001-414-05 and lot number DT3023030A on the packaging. The product was manufactured by Aurobindo Pharma in Hyderabad, India.
What should I do if I have the recalled product?
The recall does not specify a remedy, so patients should check with their healthcare provider or contact Amerisource Health Services for further instructions.
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-0156-2025 — Amerisource Health Services Amerisource Health Services Hello, I own a Amerisource Health Services that is covered by recall D-0156-2025 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-0156-2025 (December 6, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0156-2025 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.