Recalls / Class II
Class IID-0189-2025
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
- Brand name
- Duloxetine
- Generic name
- Duloxetine Hydrochloride
- Active ingredient
- Duloxetine Hydrochloride
- Route
- Oral
- NDCs
- 57237-017, 57237-018, 57237-019
- FDA application
- ANDA090778
- Affected lot / code info
- Lot # DT2023003A, DT2023007A, DT2023008A, exp. date Jan-25
Why it was recalled
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Recalling firm
- Firm
- Rising Pharma Holding, Inc.
- Manufacturer
- Rising Pharma Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Tower Center Blvd Ste 1401, East Brunswick, New Jersey 08816-1149
Distribution
- Quantity
- 73,680 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2024-12-30
- FDA classified
- 2025-01-08
- Posted by FDA
- 2025-01-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0189-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.