Breckenridge Duloxetine Capsules Recall: N-Nitroso Impurity Risk
Breckenridge Pharmaceutical recalls 30mg Duloxetine capsules due to N-nitroso-duloxetine impurity exceeding safety limits. Affected lots manufactured in Spain for US distribution.
Recall notice
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Contact the company
What happened, in plain English
Breckenridge Pharmaceutical is recalling 30mg Duloxetine Delayed-Release Capsules because they contain an impurity (N-nitroso-duloxetine) that exceeds safety limits. This could pose a health risk to people taking the medication. Read more at govinfonow.com/recall/31877-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31877-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0621-2025
Cite this page
“Breckenridge Duloxetine Capsules Recall: N-Nitroso Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31877-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk. Based on FDA recall #D-0621-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0621-2025%22&limit=1).
Why it’s dangerous
The capsules contain an impurity called N-nitroso-duloxetine that exceeds the safety limit set by the manufacturer. This impurity could potentially cause health issues when taken by people who need the medication.
Who’s affected
People with prescriptions for Duloxetine 30mg capsules who received this specific batch from the manufacturer. Those taking the medication for depression or nerve pain are most at risk.
How to tell if you have this one
Check for the NDC code 82009-030-10 and lot number 240927C on the bottle. The capsules were manufactured in Spain and distributed for US use with an expiration date of April 30, 2027.
- Brand
Breckenridge- Category
Drug
What to do — step by step
Check Your Capsules
Look for the NDC code 82009-030-10 and lot number 240927C on the bottle label.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “AZ, IN, NJ” 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 40 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 official recall notice states the product contains an impurity above 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-0621-2025 (August 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0621-2025 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.