Class II
Ongoing
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.
This recall is currently active, issued November 5, 2025. It was issued by Breckenridge Pharmaceutical, Inc..
- Recall Initiated
- October 9, 2025
- Posted
- November 5, 2025
- Recall Number
- D-0100-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 172,263 bottles
- Firm Location
- Berkeley Heights, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Distribution
U.S. Nationwide
Lot / Code Info
90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026
More recalls by Breckenridge Pharmaceutical, Inc.
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