Breckenridge Duloxetine Capsules Recall: N-nitroso-duloxetine Impurity Risk
Breckenridge Pharmaceutical recalls 60mg Duloxetine Delayed-Release Capsules due to potential N-nitroso-duloxetine impurity above FDA limits. Affected lots: NDC 82009-032-10, Lot 240539C (expiring 1/31/2027).
Recall notice
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Contact the company
What happened, in plain English
Breckenridge Pharmaceutical recalls 60mg Duloxetine Delayed-Release Capsules because they contain an impurity (N-nitroso-duloxetine) that exceeds FDA safety limits. This could pose a health risk if taken by people who need this medication. Read more at govinfonow.com/recall/31955-breckenridge-duloxetine-capsules-recall-n-nitroso-duloxetine-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31955-breckenridge-duloxetine-capsules-recall-n-nitroso-duloxetine-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0580-2025
Cite this page
“Breckenridge Duloxetine Capsules Recall: N-nitroso-duloxetine Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31955-breckenridge-duloxetine-capsules-recall-n-nitroso-duloxetine-impurity-risk. Based on FDA recall #D-0580-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0580-2025%22&limit=1).
Why it’s dangerous
The capsules contain N-nitroso-duloxetine impurities above the FDA's recommended safety level. This impurity could potentially cause health issues if taken by people who need this medication.
Who’s affected
People with prescriptions for Duloxetine Delayed-Release Capsules (60mg) who received this specific batch from the manufacturer. Those who have the NDC 82009-032-10, Lot 240539C (expiring 1/31/2027) are most at risk.
How to tell if you have this one
Check for the NDC code 82009-032-10 and lot number 240539C on the bottle. The product expires January 31, 2027.
- Brand
Breckenridge- Category
Drug
What to do — step by step
Check Product Details
Look for NDC 82009-032-10 and lot number 240539C on the bottle label.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “NJ, AZ, IN” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Indiana, New Jersey.
Recall timeline
FDA published this recall 26 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to take?
The recall indicates the product contains an impurity above FDA safety limits, so it is not safe to take.
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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-0580-2025 (July 25, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0580-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.