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-0216-2026
- 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, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
Get recall alerts
Free email alert whenever Breckenridge Pharmaceutical, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Breckenridge Pharmaceutical, Inc.