RemedyRepack Inc. recalls Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC
RemedyRepack recalls Duloxetine Delayed-Release Capsules 60mg due to N-nitroso-duloxetine impurity exceeding safety limits. Rx-only product sold in blister cards and bottles with specific NDCs.
Recall notice
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Contact the company & request your remedy
What happened, in plain English
RemedyRepack has recalled Duloxetine 60mg capsules that may contain unsafe levels of N-nitroso-duloxetine. This impurity could pose health risks, so affected users should stop using the product and contact the manufacturer. Read more at govinfonow.com/recall/32390-remedyrepack-recalls-duloxetine-60mg-capsules-with-n-nitroso-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32390-remedyrepack-recalls-duloxetine-60mg-capsules-with-n-nitroso-impurity-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0165-2025
Cite this page
“RemedyRepack recalls Duloxetine 60mg capsules with N-nitroso impurity risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32390-remedyrepack-recalls-duloxetine-60mg-capsules-with-n-nitroso-impurity-risk. Based on FDA recall #D-0165-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0165-2025%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, though the exact risk level is not specified in the recall notice.
Who’s affected
People who have purchased the recalled Duloxetine capsules from pharmacies or online retailers. Those with prescription for this medication are most at risk.
How to tell if you have this one
Check for blister cards (NDC 70518-0937-04) or bottles (NDC 70518-0937-03) with specific lot numbers and expiration dates listed in the product description.
- Brand
RemedyRepack- Category
Drug
What to do — step by step
Stop Using Product
Immediately stop using the recalled Duloxetine capsules if you have them.
Questions people ask
Is this product safe to use?
The recall states the product may contain unsafe levels of N-nitroso-duloxetine, so it is not safe to use.
How can I check if my product is recalled?
Check the product's NDC number: 70518-0937-04 for blister cards or 70518-0937-03 for bottles.
What should I do if I have the recalled product?
Stop using the product immediately and contact RemedyRepack for further instructions.
Contact RemedyRepack
We’ve drafted a message you can send RemedyRepack to request your refund or repair — edit it as you like.
Subject: Recall D-0165-2025 — RemedyRepack RemedyRepack Hello, I own a RemedyRepack that is covered by recall D-0165-2025 from RemedyRepack. 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-0165-2025 (December 2, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0165-2025 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.