Drug recall D-0100-2026
Product
Duloxetine 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.
Reason for recall
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Lots and codes
90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026
Recall details
- Recalling firm
- Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ
- Quantity
- 172,263 bottles
- Distribution
- U.S. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 9, 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.