Breckenridge Pharmaceutical recalls

16 official recalls and safety alerts involving Breckenridge Pharmaceutical since 2023-03, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Breckenridge Pharmaceutical or the relevant agency.

1. 2026-06-17
2. US
   Drugs & medicalClass II

   Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules…

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

   FDA · DrugBreckenridge Pharmaceutical, Inc.Nationwide within the United StatesOfficial notice →
3. 2026-05-13
4. US
   Drugs & medicalClass II

   Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles,…

   CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

   FDA · DrugBreckenridge Pharmaceutical, Inc.Nationwide in the USAOfficial notice →
5. 2025-12-10
6. US
   Drugs & medicalClass II

   Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe,…

   CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

   FDA · DrugBreckenridge Pharmaceutical, Inc.Nationwide within the United StatesOfficial notice →
7. 2025-11-05
8. US
   Drugs & medicalClass II

   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 →
9. 2025-09-17
10. US
    Drugs & medicalClass II

    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 →
11. 2025-08-20
12. US
    Drugs & medicalClass II

    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 →
13. 2025-08-13
14. US
    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

    FDA · DrugBreckenridge Pharmaceutical, Inc.U.S NationwideOfficial notice →
15. 2025-07-16
16. US
    Drugs & medicalClass II

    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 →
17. 2025-04-30
18. 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 →
19. 2025-04-09
20. 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 →
21. 2025-03-19
22. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L.…

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

    FDA · DrugBreckenridge Pharmaceutical, Inc.NationwideOfficial notice →
23. 2025-01-01
24. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical…

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

    FDA · DrugBreckenridge Pharmaceutical, IncNationwide in the USOfficial notice →
25. 2024-10-23
26. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L.…

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

    FDA · DrugBreckenridge Pharmaceutical, IncProduct was distributed nationwide within the United StatesOfficial notice →
27. 2024-06-26
28. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles,…

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

    FDA · DrugBreckenridge Pharmaceutical, IncNationwide in the USAOfficial notice →
29. 2024-05-15
30. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-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, IncUS Nationwide.Official notice →
31. 2023-03-22
32. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc recalls Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC…

    CGMP Deviations: Potential risk of Cross Contamination

    FDA · DrugBreckenridge Pharmaceutical, IncUSA nationwide.Official notice →