Breckenridge Duloxetine Capsules Recall: N-nitroso impurity risk
Breckenridge Pharmaceutical recalls 60mg Duloxetine capsules due to N-nitroso-duloxetine impurity exceeding FDA limits. Affected lots: 241069C (exp 05/31/2027).
Recall notice
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended 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) above FDA safety limits. This could pose a health risk to people taking the medication. Read more at govinfonow.com/recall/31342-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31342-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0522-2026
Cite this page
“Breckenridge Duloxetine Capsules Recall: N-nitroso impurity risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31342-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk. Based on FDA recall #D-0522-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0522-2026%22&limit=1).
Why it’s dangerous
The capsules contain N-nitroso-duloxetine impurities at levels above the FDA's recommended safety limit. This impurity could potentially cause health issues, though the exact risk level isn't specified in the recall notice.
Who’s affected
People who have the specific lot number 241069C of the 60mg Duloxetine capsules (90-count bottle) from Breckenridge Pharmaceutical. Those taking this medication for depression or nerve pain are most at risk.
How to tell if you have this one
Check for the lot number 241069C on the bottle label. The product is a 60mg Duloxetine Delayed-Release Capsules USP, 90-count bottle manufactured by Towa Pharmaceutical in Spain and distributed by Breckenridge Pharmaceutical.
- Brand
Breckenridge Pharmaceutical- Category
Drug
What to do — step by step
Check Product Label
Look for the lot number 241069C on the bottle label to confirm if it's affected.
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 published this recall 22 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-0522-2026 (April 21, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0522-2026 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.