Class II
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
- Recall number
- D-0188-2025
- Report date
- January 15, 2025
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Rising Pharma Holding, Inc.
- Generic names
- Not provided
- Brand names
- Not provided
- Product NDCs
- Not provided
Code and lot information
a) Lot# DT3023051A, exp. date Apr-25; b) DT3023025A, exp. date Jan-25
Distribution
Nationwide
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.