Duloxetine Delayed-Release Capsules recalled over manufacturing violations
- Recall date
- March 5, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Rising Pharma Holding, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddl…
- Recall number
- D-0277-2025
- FDA classification
- Class II
- Brand / firm
- Rising Pharma Holding, Inc.
- Sold / distributed
- Nationwide in the USA.
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, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
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