Duloxetine Delayed-Release Capsules USP 20 mg recalled over manufacturing violations
- Recall date
- December 30, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Rising Pharma Holding, Inc. recalls Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc.,…
- Recall number
- D-0189-2025
- FDA classification
- Class II
- Brand / firm
- Rising Pharma Holding, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim 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 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
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