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. Rx-only medication with specific lot numbers and expiration dates.
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 to people taking the medication. Read more at govinfonow.com/recall/31224-breckenridge-duloxetine-capsules-recall-n-nitroso-duloxetine-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31224-breckenridge-duloxetine-capsules-recall-n-nitroso-duloxetine-impurity-risk · Updated August 10, 2026 · FDA enforcement record: FDA #D-0583-2026
Cite this page
“Breckenridge Duloxetine Capsules Recall: N-nitroso-duloxetine Impurity Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31224-breckenridge-duloxetine-capsules-recall-n-nitroso-duloxetine-impurity-risk. Based on FDA recall #D-0583-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0583-2026%22&limit=1).
Why it’s dangerous
The medication contains N-nitroso-duloxetine impurities above the FDA's recommended safety level. This impurity could potentially cause health issues, though the exact risk level isn't specified in the recall notice.
Who’s affected
People with prescriptions for Duloxetine Delayed-Release Capsules (60mg) from the recalled lots. Those who have taken the medication without medical supervision are at risk.
How to tell if you have this one
Check for the product name 'Duloxetine Delayed-Release Capsules, USP, 60mg' with specific lot numbers: 241074C (exp. May 2027), 240317-240375C (exp. Feb 2027), 240316 (exp. Jan 2027), 232311 (exp. Nov 2026), or 240978C (exp. Apr 2027).
- 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- 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-0582-2026 | Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10; Lot: 241180C, Exp. Date April 2027. | 14,729 bottles. |
| D-0583-2026 | Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.; Lot: a) 241074C, Exp. Date May 2027; 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, Exp. Date February 2027; 240316,Exp. Date January 2027; 232311, Exp. Date November 2026; b) 240978C, 241052C, Exp. Date April 2027. | 359,676 bottles |
What to do — step by step
Check Product Details
Identify the lot number and expiration date on the packaging to determine if your medication is recalled.
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 13 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-0583-2026 (June 4, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0583-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.