Breckenridge Recalls Duloxetine 60 mg Due to Nitrosamine Impurity
Breckenridge recalls 16,473 bottles of Duloxetine 60 mg capsules due to CGMP deviations and nitrosamine impurity above interim limits.
Use caution until it’s fixed
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Contact the company
What happened, in plain English
Breckenridge Pharmaceutical is recalling 16,473 bottles of Duloxetine Delayed-Release Capsules USP, 60 mg because they contain a nitrosamine drug substance related impurity above the proposed interim limit. The capsules were manufactured by Towa Pharmaceutical Europe, S.L. and distributed nationwide in the United States. This recall is classified as Class II. Read more at govinfonow.com/recall/32142-breckenridge-recalls-duloxetine-60-mg-due-to-nitrosamine-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/32142-breckenridge-recalls-duloxetine-60-mg-due-to-nitrosamine-impurity · Updated October 9, 2026 · FDA enforcement record: FDA #D-0387-2025
Cite this page
“Breckenridge Recalls Duloxetine 60 mg Due to Nitrosamine Impurity.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32142-breckenridge-recalls-duloxetine-60-mg-due-to-nitrosamine-impurity. Based on FDA recall #D-0387-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0387-2025%22&limit=1).
Why it’s dangerous
The product contains a nitrosamine drug substance related impurity that exceeds the proposed interim limit due to Current Good Manufacturing Practice (CGMP) deviations. Nitrosamines are generally considered potential carcinogens, but the specific health impact of this level of impurity is not described in the provided record.
Who’s affected
Patients currently taking Duloxetine 60 mg capsules from Breckenridge Pharmaceutical who purchased them anywhere in the United States. The specific risk depends on individual health conditions and the severity of potential impurity exposure, which is not detailed in this record.
How to tell if you have this one
Check your medication bottle for the following details: Brand: Breckenridge Pharmaceutical; Product: Duloxetine Delayed-Release Capsules USP, 60 mg; NDC#: 51991-748-10. Verify if you have Lot # 240987C or Lot # 241014C with an expiration date of 04/2027.
- Brand
Breckenridge Pharmaceutical- 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
US 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-0387-2025 | Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10; Lot # 240987C, exp. date 04/2027 241014C, exp. date 04/2027 | 16,473 bottles |
| D-0388-2025 | Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922; Lot # 230201C, exp. date 01/2026 230471C, exp. date 01/2026 230288C, exp. date 01/2026 | 343,344 bottles |
What to do — step by step
Contact Your Pharmacist
Reach out to your pharmacy or healthcare provider immediately to discuss the recall and determine if you should continue taking this medication.
Check Lot Numbers
Verify if your bottle matches Lot # 240987C or Lot # 241014C with an expiration date of 04/2027.
Do Not Stop Abruptly Without Advice
The record does not specify a remedy such as return or discard, so do not stop taking prescribed medication without consulting your doctor first.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US 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 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-0387-2025 (April 14, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0387-2025 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.