Duloxetine Delayed-Release Capsules recalled over manufacturing violations
- Recall date
- October 9, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 519…
- Recall number
- D-0100-2026
- FDA classification
- Class II
- Brand / firm
- Breckenridge Pharmaceutical, Inc.
- Sold / distributed
- U.S. Nationwide
Why it was recalled
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
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, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
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