Brand
Breckenridge Pharmaceutical, Inc
17 federal recalls on file, showing the 3 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Breckenridge Pharmaceutical, Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-09-17FDA-DrugClass IIDuloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
- 2025-08-20FDA-DrugClass IIDuloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- 2025-08-13FDA-DrugClass IIDuloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Get notified about new Breckenridge Pharmaceutical, Inc recalls
Free weekly digest. We email when a new federal recall affects Breckenridge Pharmaceutical, Inc or anything else in your household.
Get the Sunday BriefExplore other recall topics
By hazard
By state
Get alerts for your household