Breckenridge Duloxetine Capsules Recall: N-nitroso Impurity Risk
Breckenridge Pharmaceutical recalls 20mg Duloxetine capsules due to potential N-nitroso impurity exceeding FDA safety limits. Affected lots may pose health risks.
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 is recalling 20mg Duloxetine Delayed-Release Capsules from specific lots due to a chemical impurity that could exceed safe levels. This recall affects patients using prescription antidepressants who may face health risks from the impurity. Read more at govinfonow.com/recall/32510-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32510-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0009-2025
Cite this page
“Breckenridge Duloxetine Capsules Recall: N-nitroso Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32510-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk. Based on FDA recall #D-0009-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0009-2025%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 if the medication is taken as prescribed, though the exact risk level isn't specified in the recall.
Who’s affected
Prescription antidepressant users who purchased the specific lot (220128) of 20mg Duloxetine capsules from the recalled batches. Patients with depression or anxiety conditions are most at risk.
How to tell if you have this one
Check for the lot number 220128 on the bottle label. The product is a 20mg Duloxetine Delayed-Release Capsules, 500-count bottle with NDC 51991-746-05.
- Brand
Breckenridge- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number 220128 on the bottle label to confirm if your product is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 13 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-0009-2025 (October 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0009-2025 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.