Multi event Drug Recall Enforcement Report Class II voluntary initiated by Breckenridge Pharmaceutical, Inc., originally initiated on 02-28-2025 for the product Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10 The product was recalled due to cgmp deviations: presence of n-nitroso-duloxetine impurity above fda 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-0270-2025 | 02-28-2025 | 03-19-2025 | Class II | 14,749 bottles. | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Ongoing |
| D-0271-2025 | 02-28-2025 | 03-19-2025 | Class II | 11,125 bottles. | Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Ongoing |
| D-0269-2025 | 02-28-2025 | 03-19-2025 | Class II | 11,100 bottles. | Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Ongoing |
Recalled Products
