Multi event Drug Recall Enforcement Report Class II voluntary initiated by Rising Pharma Holding, Inc., originally initiated on 11-19-2024 for the product Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, 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-0107-2025 | 11-19-2024 | 12-11-2024 | Class II | 233,003 bottles | Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit | Ongoing |
| D-0106-2025 | 11-19-2024 | 12-11-2024 | Class II | 122,925 bottles | Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit | Ongoing |
| D-0105-2025 | 11-19-2024 | 12-11-2024 | Class II | 209,376 bottles | Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit | Ongoing |
Recalled Products
