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Unrated Drug recall · FDA · Published April 29, 2024

Breckenridge Duloxetine Capsules Recall: N-nitroso Impurity Risk

Breckenridge Pharmaceutical recalls 60mg Duloxetine capsules due to potential N-nitroso impurity exceeding FDA limits. Affected bottles have specific NDC codes and expiration dates. Consumers should contact the company for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0484-2024DrugBreckenridge ›
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Contact the company

Recalling firmBreckenridge Pharmaceutical, Inc15 Massirio Dr Ste 201 · Berlin, CT 06037-2352
✎ GovInfoNow plain-language explainer

Breckenridge Pharmaceutical is recalling 60mg Duloxetine Delayed-Release Capsules because they contain an impurity (N-nitroso-duloxetine) that exceeds the FDA's safety limit. This could pose a health risk if taken as directed. Read more at govinfonow.com/recall/32702-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32702-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0484-2024

Cite this page

“Breckenridge Duloxetine Capsules Recall: N-nitroso Impurity Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32702-breckenridge-duloxetine-capsules-recall-n-nitroso-impurity-risk. Based on FDA recall #D-0484-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0484-2024%22&limit=1).

The FDA announced on April 29, 2024, that Breckenridge Pharmaceutical, Inc. is recalling Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles due to CGMP deviations involving an N-nitroso-duloxetine impurity above the FDA recommended interim limit.

How to tell if you have it

  • Brand: Breckenridge
  • Product: Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles
  • Manufacturer: Towa Pharmaceutical Europe, S.L.
  • Distributor: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ
  • NDC: 51991-748-90
  • Lot codes and expiration dates: 230028C (Exp. Nov 2025), 230106C (Exp. Dec 2025), 230170C (Exp. Dec 2025), 220039 (Exp. Dec 2024), 220363 (Exp. Feb 2025)
  • Distribution: US Nationwide
  • Units affected: 281,554 bottles

The hazard

According to the FDA, the recall is due to CGMP deviations resulting in the presence of N-nitroso-duloxetine impurity above the FDA recommended interim limit.

Context

GovInfoNow's records show Breckenridge Pharmaceutical, Inc. has 20 other recalls on record since October 21, 2015. Other recent recalls of similar products include Breckenridge Duloxetine Capsules Recall: N-nitroso impurity risk (June 4, 2026), Breckenridge Duloxetine Capsules Recall: N-nitroso impurity risk (April 21, 2026), and Breckenridge Duloxetine Capsules Recall: N-nitroso-duloxetine Impurity Risk (November 24, 2025). Other recent recalls of similar products include Asclemed Duloxetine Capsules Recall: Nitrosamine Impurity Risk (May 14, 2026), Ajanta Pharma Recalls Duloxetine Capsules Due to Nitrosamine Impurity Risk (April 29, 2026), and Ajanta Pharma recalls Duloxetine capsules due to potential impurity risk (April 29, 2026).

How to tell if you have this one

Check for the NDC code 51991-748-90 on the bottle. The capsules have specific expiration dates: Dec 2024, Feb 2025, or Nov 2025.

  • Brand
    Breckenridge
  • Category
    Drug
FDA recall event · 3 products

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
    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 numberProduct, codes & lotsQuantity
D-0482-2024Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.; 220265: Exp. Feb 2025 220088: Exp. Nov 2024 220267: Exp. Feb 2025 220256: Exp. Feb 2025 220225: Exp. Jan 2025 220269: Exp. Feb 2025281,554/90 & 1000 count bottles
D-0483-2024Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.; 220456: Exp. Feb 20257,188/ 500 count bottles
D-0484-2024Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90.; 230028C: Exp. Nov 2025 230106C: Exp. Dec 2025 230170C: Exp. Dec 2025 220039: Exp. Dec 2024 220363: Exp. Feb 2025281,554/90 count bottles
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the NDC code 51991-748-90 and expiration dates listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

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.

1. Firm started the recall: Apr 29, 202412. FDA classified it Class II: May 4, 202423. Published in FDA’s Enforcement Report: May 15, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Breckenridge Duloxetine Capsules Recall: N-nitroso impurity risk
Breckenridge PharmaceuticalBreckenridge Duloxetine Capsules Recall: N-nitroso-duloxetine Impurity Risk
BreckenridgeBreckenridge Duloxetine Capsules Recall: N-nitroso-duloxetine Impurity Risk
BreckenridgeAsclemed Duloxetine Capsules Recall: Nitrosamine Impurity Risk
Asclemed USAAjanta Pharma Recalls Duloxetine Capsules Due to Nitrosamine Impurity Risk
Ajanta Pharma

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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-0484-2024 (April 29, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0484-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on September 23, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA