Drug recall
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm…
FDA recall event 96074 · Class II · Rising Pharma Holding, Inc.
Key facts
| Event ID | 96074 |
|---|---|
| Recall numbers | D-0188-2025, D-0189-2025, D-0190-2025 |
| Recalling firm | Rising Pharma Holding, Inc. |
| Product type | Drugs |
| Products | 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, 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, Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. |
| Initiation date | Dec 30, 2024 |
| Report date | Jan 15, 2025 |
| City | East Brunswick |
| State | NJ |
| Country | United States |
| FEI number | 3015784623 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: