FDA Recall D-0189-2025
Rising Pharma Holding, Inc. · East Brunswick, NJ
Class II Ongoing 500 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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
Reason for recall
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Recall record
- Recall number
D-0189-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2024-12-30
- Classified by FDA Center
- 2025-01-08
- FDA published
- 2025-01-15
- Recalling firm
- Rising Pharma Holding, Inc.
- Firm location
- East Brunswick, NJ
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.