Multi event Drug Recall Enforcement Report Class II voluntary initiated by Rising Pharma Holding, Inc., originally initiated on 12-30-2024 for the product 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 The product was recalled due to cgmp deviations; presence of n-nitroso-duloxetine impurity above recommended interim limit.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0188-2025 | 12-30-2024 | 01-15-2025 | Class II | 42,527 bottles | 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. | Ongoing |
| D-0189-2025 | 12-30-2024 | 01-15-2025 | Class II | 73,680 bottles | 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 | CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Ongoing |
| D-0190-2025 | 12-30-2024 | 01-15-2025 | Class II | 244,460 bottles | 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 | CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Ongoing |
Recalled Products
