ⓘ How this was built
Data sources
- FDA drug enforcement reports via openFDA
Method
Enforcement reports whose product NDC list includes this exact package NDC, newest first, with FDA's classification (I = reasonable probability of serious harm, II = temporary or reversible harm, III = unlikely to cause harm) and the recall's current status. Reports for other packages of the same drug are not shown here; 275 of the last year's Class I/II reports carry no NDC at all and cannot be matched. To check: search the recall number on openFDA or FDA's enforcement reports.
Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.
Class II · OngoingJun 4, 2026
Breckenridge Pharmaceutical, Inc. — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · OngoingJun 4, 2026
Breckenridge Pharmaceutical, Inc. — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · OngoingApr 21, 2026
Breckenridge Pharmaceutical, Inc. — CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II · OngoingNov 24, 2025
Breckenridge Pharmaceutical, Inc. — CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II · OngoingOct 9, 2025
Breckenridge Pharmaceutical, Inc. — CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Class II · OngoingJul 15, 2025
Breckenridge Pharmaceutical, Inc. — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Class II · OngoingJun 30, 2025
Breckenridge Pharmaceutical, Inc. — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · OngoingApr 14, 2025
Breckenridge Pharmaceutical, Inc — CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · OngoingApr 14, 2025
Breckenridge Pharmaceutical, Inc — CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · OngoingMar 26, 2025
Breckenridge Pharmaceutical, Inc. — CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Class II · OngoingFeb 28, 2025
Breckenridge Pharmaceutical, Inc. — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · OngoingFeb 28, 2025
Breckenridge Pharmaceutical, Inc. — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · OngoingFeb 28, 2025
Breckenridge Pharmaceutical, Inc. — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · OngoingDec 6, 2024
Breckenridge Pharmaceutical, Inc — CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · OngoingDec 6, 2024
Breckenridge Pharmaceutical, Inc — CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · CompletedOct 10, 2024
Breckenridge Pharmaceutical, Inc — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · TerminatedMay 17, 2024
Breckenridge Pharmaceutical, Inc — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · OngoingApr 29, 2024
Breckenridge Pharmaceutical, Inc — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · OngoingApr 29, 2024
Breckenridge Pharmaceutical, Inc — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · OngoingApr 29, 2024
Breckenridge Pharmaceutical, Inc — CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit