Breckenridge Duloxetine Capsules Recall: N-nitroso impurity risk
Breckenridge recalls 20mg Duloxetine capsules with N-nitroso impurity above FDA limits. Stop using if you have affected lots. Details: NDC 51991-746-05, Lot 240098C.
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 recalls 20mg Duloxetine Delayed-Release Capsules due to a chemical impurity that could pose health risks. This recall affects specific batches made in Spain and distributed in the U.S. The impurity level exceeds FDA safety thresholds, requiring immediate action. Read more at govinfonow.com/recall/32258-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32258-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0271-2025
Cite this page
“Breckenridge Duloxetine Capsules Recall: N-nitroso impurity risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32258-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk. Based on FDA recall #D-0271-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0271-2025%22&limit=1).
Why it’s dangerous
The recall involves a chemical impurity called N-nitroso-duloxetine that exceeds FDA safety limits. This impurity could potentially cause health issues, though the exact risk level is not specified in the recall notice.
Who’s affected
People with prescriptions for Duloxetine 20mg capsules from the recalled batches (NDC 51991-746-05, Lot 240098C) are affected. Those using the product without a prescription are not at risk.
How to tell if you have this one
Check for the NDC code 51991-746-05 and lot number 240098C on the bottle. The product was manufactured in Martorelles, Barcelona, Spain, and distributed by Breckenridge Pharmaceuticals in the U.S.
- Brand
Breckenridge- Category
Drug
All 3 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- NDC
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
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0269-2025 | Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10; Lot#: 240301C, Expiration: 01/2027. | 11,100 bottles. |
| D-0270-2025 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10; Lot#: 240225C, Expiration: 01/2027 | 14,749 bottles. |
| D-0271-2025 | Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05; Lot#: 240098C, Expiration: 01/2027. | 11,125 bottles. |
What to do — step by step
Check Product Details
Look for the NDC code 51991-746-05 and lot number 240098C on the bottle label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 19 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-0271-2025 (February 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0271-2025 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.