DrugJun 17, 2026
Duloxetine Delayed-Release Capsules, USP, 60mg recall — FDA D-0583-2026
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class IIFDA: OngoingBreckenridge Pharmaceutical, Inc.
Recall history in this database
Classification mix: Class II: 14.
DrugJun 17, 2026
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles recall — FDA D-0582-2026
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class IIFDA: OngoingBreckenridge Pharmaceutical, Inc.
DrugMay 13, 2026
Duloxetine Delayed-Release Capsules USP, 60mg recall — FDA D-0522-2026
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class IIFDA: OngoingBreckenridge Pharmaceutical, Inc.
DrugDec 10, 2025
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles recall — FDA D-0216-2026
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class IIFDA: OngoingBreckenridge Pharmaceutical, Inc.
DrugDec 10, 2025
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles recall — FDA D-0215-2026
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class IIFDA: OngoingBreckenridge Pharmaceutical, Inc.
DrugNov 5, 2025
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90) recall — FDA D-0100-2026
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Class IIFDA: OngoingBreckenridge Pharmaceutical, Inc.
DrugSep 17, 2025
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle recall — FDA D-0621-2025
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Class IIFDA: OngoingBreckenridge Pharmaceutical, Inc.
DrugAug 20, 2025
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle recall — FDA D-0580-2025
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class IIFDA: OngoingBreckenridge Pharmaceutical, Inc.
DrugJul 16, 2025
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles recall — FDA D-0511-2025
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class IIFDA: OngoingBreckenridge Pharmaceutical, Inc.
DrugApr 30, 2025
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles recall — FDA D-0387-2025
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class IIFDA: OngoingBreckenridge Pharmaceutical, Inc
DrugApr 30, 2025
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90) recall — FDA D-0388-2025
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class IIFDA: OngoingBreckenridge Pharmaceutical, Inc
DrugApr 9, 2025
Duloxetine Delayed-Release Capsules, USP, 30 mg recall — FDA D-0308-2025
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Class IIFDA: OngoingBreckenridge Pharmaceutical, Inc.
DrugJan 1, 2025
Duloxetine Delayed-Release Capsules, USP, 30mg recall — FDA D-0161-2025
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class IIFDA: OngoingBreckenridge Pharmaceutical, Inc
DrugJan 1, 2025
Duloxetine Delayed-Release Capsules, USP, 60 mg recall — FDA D-0162-2025
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class IIFDA: OngoingBreckenridge Pharmaceutical, Inc
Understanding this recall history
This page summarizes recall records in which the official source identifies Breckenridge Pharmaceutical, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.