Breckenridge recalls duloxetine 60 mg capsules over impurity above FDA's recommended limit
The capsules contain N-nitroso-duloxetine, an impurity, above the limit the FDA recommends, and the notice also cites manufacturing practice deviations.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- 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.; Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L.…
- Hazard
- CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- Units
- 7389 bottles; 3397 bottles
- Where sold
- Nationwide within the United States
- FDA classification
- Class II · Ongoing
- Classified by FDA
- December 3, 2025
- Recall started
- November 24, 2025
- FDA enforcement report
- December 10, 2025
- Identifiers
- Codes: Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
- FDA recall number: D-0216-2026
- Codes: Lot #: 240947C, 240962C, Exp. Date 04/2027
- FDA recall number: D-0215-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- 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. | Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.
- Reason for recall
- CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide within the United States
- Quantity
- 7389 bottles; 3397 bottles
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