Duloxetine Delayed-Release Capsules recalled over manufacturing violations
- Recall date
- July 15, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.…
- Recall number
- D-0552-2025
- FDA classification
- Class II
- Brand / firm
- Breckenridge Pharmaceutical, Inc.
- Sold / distributed
- U.S Nationwide
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment 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, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
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