Duloxetine Delayed-Release Capsules recalled over manufacturing violations
- Recall date
- November 24, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals E…
- Recall number
- D-0215-2026
- FDA classification
- Class II
- Brand / firm
- Breckenridge Pharmaceutical, Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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