D-0216-2026 Class II Ongoing
FDA drug recall D-0216-2026 was initiated by Breckenridge Pharmaceutical, Inc. on November 24, 2025 and is designated Class II. Reason for recall: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit The recall status is ongoing. Affected quantity: 7389 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 10, 2025
- Initiation Date
- November 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7389 bottles
Product Description
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.
Reason for Recall
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.