Recall Atlas
Drugs & medicalClass II

Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.…

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit

Read the official notice →
Date
2025-08-13
Country
United States
Brand
Breckenridge Pharmaceutical
Product
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles,…
Classification
Class II
Units
U.S Nationwide
Category
Drugs & medical
Source
FDA · Drug

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Breckenridge Pharmaceutical recalls

  1. 2025-11-05
  2. US
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    Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC…

    CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.

    FDA · DrugBreckenridge Pharmaceutical, Inc.U.S. NationwideOfficial notice →
  3. 2025-09-17
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    Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical…

    CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

    FDA · DrugBreckenridge Pharmaceutical, Inc.AZ, IN, NJOfficial notice →
  5. 2025-08-20
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    Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical…

    CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

    FDA · DrugBreckenridge Pharmaceutical, Inc.NJ, AZ, INOfficial notice →
  7. 2025-07-16
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    Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.…

    CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

    FDA · DrugBreckenridge Pharmaceutical, Inc.U.S. NationwideOfficial notice →
  9. 2025-04-30
  10. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L.,…

    CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

    FDA · DrugBreckenridge Pharmaceutical, IncUS Nationwide.Official notice →
  11. 2025-04-09
  12. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical…

    CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.

    FDA · DrugBreckenridge Pharmaceutical, Inc.Nationwide in the USOfficial notice →
All 16 Breckenridge Pharmaceutical recalls →

Other drugs & medical recalls in the United States

  1. 2025-08-13
  2. US
    Drugs & medicalClass II

    Direct Rx recalls Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc.,…

    CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

    FDA · DrugDirect RxNationwideOfficial notice →
  3. US
    Drugs & medicalClass II

    Alembic Pharmaceuticals Limited recalls Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v…

    CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

    FDA · DrugAlembic Pharmaceuticals LimitedNationwide in the USA.Official notice →
  4. US
    Drugs & medicalClass II

    AEQUITA PHARMACY recalls Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose…

    Lack of Processing Controls.

    FDA · DrugAEQUITA PHARMACYMAOfficial notice →
  5. 2025-08-06
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    Fresenius Kabi USA, LLC recalls LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.

    Potential for external cassette leaks

    FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA,…Official notice →
  7. US
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    3M Company recalls 3M Ranger Irrigation Fluid Warming Set, REF 24750

    Notice was issued to clarify flow rates related to the inlet fluid temperature.

    FDA · Device3M CompanyUS (nationwide) and Argentina, Australia, Austria, Belgium, Bosnia and…Official notice →
  8. US
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    Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.

    Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride,…

    FDA · DeviceSiemens Healthcare Diagnostics Incworldwide distribution - US Nationwide and the countries of Canada, Chile,…Official notice →
See all drugs & medical recalls →