Breckenridge Pharmaceutical, Inc. Recalls

All product recalls associated with Breckenridge Pharmaceutical, Inc..

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Recall Summary

Total Recalls

18

Past Year

13

Class I (Serious)

0

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–18 of 18 recalls

Duloxetine Capsules (Breckenridge) – Impurity Limit Exceeded (2025)

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

Class II

FDANov 24, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Duloxetine Capsules (Breckenridge) – Impurity Limit Exceeded (2025)

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

Class II

FDANov 24, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Duloxetine Capsules 60mg (Breckenridge) – Impurity Concerns (2025)

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

Class II

FDAOct 9, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Duloxetine Capsules (Breckenridge) - CGMP Impurity (2025)

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

Class II

FDAAug 8, 2025AZ, IN, NJ• Breckenridge Pharmaceutical, Inc.

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

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

Class II

FDAJul 25, 2025AZ, IN, NJ• Breckenridge Pharmaceutical, Inc.

Duloxetine Capsules (Breckenridge Pharmaceutical) – Impurity Concern (2025)

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

Class II

FDAJul 15, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Duloxetine Capsules (Breckenridge) – CGMP Impurity (2025)

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

Class II

FDAJun 30, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

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

Class II

FDAApr 14, 2025Nationwide• Breckenridge Pharmaceutical, Inc

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

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

Class II

FDAApr 14, 2025Nationwide• Breckenridge Pharmaceutical, Inc

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

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

Class II

FDAMar 26, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Duloxetine Capsules 30mg (Breckenridge) – Nitrosamine Impurity (2025)

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

Class II

FDAFeb 28, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Duloxetine Capsules 20mg (Breckenridge) – Nitrosamine Impurity (2025)

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

Class II

FDAFeb 28, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Duloxetine Capsules 60mg (Breckenridge) – Nitrosamine Impurity (2025)

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

Class II

FDAFeb 28, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Duloxetine Capsules 30mg (Breckenridge) – CGMP Impurity Limit (2024)

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

Class II

FDADec 6, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Duloxetine Capsules 60mg (Breckenridge) – CGMP Impurity Limit (2024)

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

Class II

FDADec 6, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2024)

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

Class II

FDAApr 29, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2024)

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

Class II

FDAApr 29, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2024)

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

Class II

FDAApr 29, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Stay Informed

Breckenridge Pharmaceutical, Inc. Recalls

Recall Summary

Duloxetine Capsules (Breckenridge) – Impurity Limit Exceeded (2025)

Duloxetine Capsules (Breckenridge) – Impurity Limit Exceeded (2025)

Duloxetine Capsules 60mg (Breckenridge) – Impurity Concerns (2025)

Duloxetine Capsules (Breckenridge) - CGMP Impurity (2025)

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

Duloxetine Capsules (Breckenridge Pharmaceutical) – Impurity Concern (2025)

Duloxetine Capsules (Breckenridge) – CGMP Impurity (2025)

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

Duloxetine Capsules 30mg (Breckenridge) – Nitrosamine Impurity (2025)

Duloxetine Capsules 20mg (Breckenridge) – Nitrosamine Impurity (2025)

Duloxetine Capsules 60mg (Breckenridge) – Nitrosamine Impurity (2025)

Duloxetine Capsules 30mg (Breckenridge) – CGMP Impurity Limit (2024)

Duloxetine Capsules 60mg (Breckenridge) – CGMP Impurity Limit (2024)

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2024)

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2024)

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2024)