Breckenridge Duloxetine Capsules Recall: N-nitroso-duloxetine Impurity Risk
Breckenridge Pharmaceutical recalls 60mg Duloxetine Delayed-Release Capsules due to N-nitroso-duloxetine impurity exceeding FDA limits. Affected lots manufactured in Spain, distributed in the US. Consumers should contact for remedy.
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 recalled 60mg Duloxetine Delayed-Release Capsules from specific lots due to a chemical impurity that could pose health risks. This recall affects prescription medication users who purchased the affected lots. Read more at govinfonow.com/recall/31630-breckenridge-duloxetine-capsules-recall-n-nitroso-duloxetine-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31630-breckenridge-duloxetine-capsules-recall-n-nitroso-duloxetine-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0216-2026
Cite this page
“Breckenridge Duloxetine Capsules Recall: N-nitroso-duloxetine Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31630-breckenridge-duloxetine-capsules-recall-n-nitroso-duloxetine-impurity-risk. Based on FDA recall #D-0216-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0216-2026%22&limit=1).
Why it’s dangerous
The capsules contain N-nitroso-duloxetine impurities above the FDA's safety limit. This impurity could potentially cause health issues, though the exact risk level isn't specified in the recall notice.
Who’s affected
Prescription medication users who purchased the recalled Duloxetine capsules from specific lots manufactured by Towa Pharmaceuticals in Spain. People with depression or other conditions treated with this medication are most at risk.
How to tell if you have this one
Check for the lot numbers 240534C (expires Jan 2027) or 240977C (expires Apr 2027) on the bottle. The product is a 60mg Duloxetine Delayed-Release Capsules, 1000-count bottle, prescription-only medication.
- Brand
Breckenridge- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide within the United States
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0215-2026 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.; Lot #: 240947C, 240962C, Exp. Date 04/2027 | 3397 bottles | 82009-029-05, 82009-030-10, 82009-032-10, 82009-031-30, 82009-031-90 |
| D-0216-2026 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.; Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027. | 7389 bottles | 51991-746-06, 51991-746-90, 51991-746-05, 51991-747-33, 51991-747-90, 51991-747-10, 51991-748-33, 51991-748-90, 51991-748-10, 51991-750-33, 51991-750-90, 51991-750-05, 51991-750-10 |
What to do — step by step
Check Product Details
Look for the lot numbers 240534C or 240977C on the bottle label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “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 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-0216-2026 (November 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0216-2026 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.