Class II
Ongoing
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.
This recall is currently active, issued August 13, 2025. It was issued by Breckenridge Pharmaceutical, Inc..
- Recall Initiated
- July 15, 2025
- Posted
- August 13, 2025
- Recall Number
- D-0552-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,829 60-count bottles
- Firm Location
- Berkeley Heights, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Distribution
U.S Nationwide
Lot / Code Info
Lot: 230836C, Exp.: 02/28/2026
More recalls by Breckenridge Pharmaceutical, Inc.
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