Class II
Ongoing
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.
This recall is currently active, issued July 16, 2025. It was issued by Breckenridge Pharmaceutical, Inc..
- Recall Initiated
- June 30, 2025
- Posted
- July 16, 2025
- Recall Number
- D-0511-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 12,242 30-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 FDA recommended interim limit
Distribution
U.S. Nationwide
Lot / Code Info
Lot # 230199, Exp. Date 01/31/2026
More recalls by Breckenridge Pharmaceutical, Inc.
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Dec 10, 2025 · Class II
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Nov 5, 2025 · Class II
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Sep 17, 2025 · Class II
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