Drug recall D-0216-2026
Product
Duloxetine 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.
Reason for recall
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Lots and codes
Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
Recall details
- Recalling firm
- Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ
- Quantity
- 7389 bottles
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 24, 2025
Related products
- Duloxetine – drug information
- NDC 51991-747 Duloxetine Delayed-Release · Duloxetine Hydrochloride 30 mg/1 · Breckenridge Pharmaceutical, Inc.
- NDC 51991-750 Duloxetine Delayed-Release · Duloxetine Hydrochloride 40 mg/1 · Breckenridge Pharmaceutical, Inc.
- NDC 51991-748 Duloxetine Delayed-Release · Duloxetine Hydrochloride 60 mg/1 · Breckenridge Pharmaceutical, Inc.
- NDC 51991-746 Duloxetine Delayed-Release · Duloxetine Hydrochloride 20 mg/1 · Breckenridge Pharmaceutical, Inc.