Breckenridge
5 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Breckenridge and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-06-17FDA-DrugClass IIBreckenridge Duloxetine 60mg recalled for impurity risk
Breckenridge Pharmaceutical is recalling specific lots of Duloxetine Delayed-Release Capsules 60mg due to higher-than-acceptable levels of a chemical impurity called N-nitroso-duloxetine. This impurity was found during manufacturing quality checks. The recall affects about 360,000 bottles distributed nationwide.
- 2026-06-17FDA-DrugClass IIBreckenridge Duloxetine capsules recalled for impurity concern
Breckenridge Pharmaceutical is recalling one lot of Duloxetine Delayed-Release Capsules 30mg due to the presence of N-nitroso-duloxetine impurity above FDA's recommended interim limit. This is a manufacturing quality issue. No injuries have been reported.
- 2025-12-10FDA-DrugClass IIDuloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- 2025-12-10FDA-DrugClass IIDuloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- 2025-11-05FDA-DrugClass IIDuloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
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