FDA Drug recall D-0511-2025
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelon…
- FDA Drug
- Class II
- ongoing
- Published 2025-07-16
On 2025-07-16 the FDA classified a Class II recall of Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelon… by Breckenridge Pharmaceutical, citing CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0511-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-30 |
| Published | 2025-07-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Breckenridge Pharmaceutical |
| Distribution | US |
Product
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Identifiers
| ndc | 51991-746-06 |
|---|---|
| ndc | 51991-746-90 |
| ndc | 51991-746-05 |
| ndc | 51991-747-33 |
| ndc | 51991-747-90 |
| ndc | 51991-747-10 |
| ndc | 51991-748-33 |
| ndc | 51991-748-90 |
| ndc | 51991-748-10 |
| ndc | 51991-750-33 |
| ndc | 51991-750-90 |
| ndc | 51991-750-05 |
| ndc | 51991-750-10 |
| code_info | Lot # 230199, Exp. Date 01/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0511-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.