Recalls / Class II
Class IID-0277-2025
Product
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
- 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 #: DTB23111A, Exp 8/31/2025
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, N/A, East Brunswick, New Jersey 08816-1149
Distribution
- Quantity
- 1223 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2025-03-05
- FDA classified
- 2025-03-14
- Posted by FDA
- 2025-03-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0277-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.