Breckenridge Duloxetine Capsules Recall: N-nitroso Impurity Risk
Breckenridge Pharmaceutical recalls 60mg Duloxetine capsules due to potential N-nitroso impurity above FDA limits. Affected lots: 230035C (exp 11/30/2025) and 230101C (exp 12/31/2025).
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 60mg Duloxetine Delayed-Release Capsules because they contain an impurity (N-nitroso-duloxetine) that exceeds FDA safety limits. This could pose a health risk, though the specific danger isn't detailed in the recall. Read more at govinfonow.com/recall/32664-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32664-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0562-2024
Cite this page
“Breckenridge Duloxetine Capsules Recall: N-nitroso Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32664-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk. Based on FDA recall #D-0562-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0562-2024%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, but the exact risk isn't specified in the recall notice.
Who’s affected
People with prescriptions for Duloxetine who bought the recalled 60mg capsules from the listed lots. Those taking the medication for depression or nerve pain are most at risk.
How to tell if you have this one
Check the product label for the NDC code 51991-748-90 and lot numbers 230035C (expires 11/30/2025) or 230101C (expires 12/31/2025).
- Brand
Breckenridge- Category
Drug
What to do — step by step
Check Product Label
Look for the NDC code 51991-748-90 and lot numbers 230035C or 230101C on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0562-2024 (May 17, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0562-2024 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.