MedicineWatch US
Class II Recall

Breckenridge Pharmaceutical, Inc.

Product
Duloxetine 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.
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Classification
Class II
Status
Ongoing
Lot
Lot: 230836C, Exp.: 02/28/2026
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Breckenridge Pharmaceutical, Inc. — Class II Recall | MedicineWatch US