Class II
Ongoing
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.
This recall is currently active, issued December 10, 2025. It was issued by Breckenridge Pharmaceutical, Inc..
- Recall Initiated
- November 24, 2025
- Posted
- December 10, 2025
- Recall Number
- D-0216-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 7389 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 the FDA recommended limit
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
More recalls by Breckenridge Pharmaceutical, Inc.
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Sep 17, 2025 · Class II
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Aug 20, 2025 · Class II
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