Breckenridge Duloxetine Capsules Recall: N-nitroso Impurity Risk
Breckenridge recalls 30mg Duloxetine capsules (NDC 51991-747-90) due to N-nitroso-duloxetine impurity exceeding FDA limits. Affected lots may pose health risks.
Lower-risk recall
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Contact the company
What happened, in plain English
Breckenridge is recalling 30mg Duloxetine Delayed-Release Capsules (90-count bottles) because they contain an impurity that exceeds FDA safety limits. This could potentially cause health risks if taken. Read more at govinfonow.com/recall/32380-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32380-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0161-2025
Cite this page
“Breckenridge Duloxetine Capsules Recall: N-nitroso Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32380-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk. Based on FDA recall #D-0161-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0161-2025%22&limit=1).
Why it’s dangerous
The capsules contain N-nitroso-duloxetine impurities above the FDA's recommended safety level. This impurity could potentially cause health issues if taken, though the exact risk level is not specified in the recall.
Who’s affected
Prescription patients who received the specific lot number (222205C) of Duloxetine capsules from the manufacturer. Those with medical conditions requiring this medication are most at risk.
How to tell if you have this one
Check for the product name 'Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles' with NDC 51991-747-90. The affected lot number is 222205C, expiring November 2025.
- 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 in the US- 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-0161-2025 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.; Lot # 222205C, exp. date 11/2025 | 163,883 bottles |
| D-0162-2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.; Lot # 230077C, exp. date 11/2025 | 76,968 bottles |
What to do — step by step
Check Product Details
Verify the lot number on the bottle label; affected units have lot 222205C.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 26 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.
Similar recalls
Latest drug recalls
Keep exploring
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-0161-2025 (December 6, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0161-2025 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.