Breckenridge Duloxetine Capsules Recall: N-nitroso impurity risk
Breckenridge Pharmaceuticals recalls 40mg Duloxetine capsules due to potential N-nitroso impurity above FDA limits. Affected lots may pose health risks; contact for details.
Lower-risk recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Contact the company
What happened, in plain English
Breckenridge Pharmaceuticals is recalling 40mg Duloxetine Delayed-Release Capsules because they contain an impurity (N-nitroso-duloxetine) that exceeds FDA safety limits. This could pose health risks to people taking the medication. Read more at govinfonow.com/recall/32007-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32007-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0511-2025
Cite this page
“Breckenridge Duloxetine Capsules Recall: N-nitroso impurity risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32007-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk. Based on FDA recall #D-0511-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0511-2025%22&limit=1).
Why it’s dangerous
The capsules contain N-nitroso-duloxetine impurities above the FDA's interim safety limit. This impurity could potentially cause health issues, though the exact risk level is not specified in the recall.
Who’s affected
People with prescriptions for Duloxetine 40mg capsules from the recalled lots are affected. Those with medical conditions requiring this medication are at higher risk.
How to tell if you have this one
Check for the product name 'Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles' with the lot number 230199 and expiration date 01/31/2026.
- Brand
Breckenridge- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number 230199 and expiration date 01/31/2026 on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 16 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.
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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-0511-2025 (June 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0511-2025 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.