Multi event Drug Recall Enforcement Report Class II voluntary initiated by Breckenridge Pharmaceutical, Inc, originally initiated on 04-14-2025 for the product Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10 The product was recalled due to cgmp deviations: presence of nitrosamine drug substance related impurity above the proposed 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-0387-2025 | 04-14-2025 | 04-30-2025 | Class II | 16,473 bottles | Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Ongoing |
| D-0388-2025 | 04-14-2025 | 04-30-2025 | Class II | 343,344 bottles | Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Ongoing |
Recalled Products
