FDA Drug recall D-0215-2026
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrel…
- FDA Drug
- Class II
- ongoing
- Published 2025-12-10
On 2025-12-10 the FDA classified a Class II recall of Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrel… by Breckenridge Pharmaceutical, citing CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0215-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-24 |
| Published | 2025-12-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Breckenridge Pharmaceutical |
| Distribution | US |
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.
Reason
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Identifiers
| ndc | 82009-029-05 |
|---|---|
| ndc | 82009-030-10 |
| ndc | 82009-032-10 |
| ndc | 82009-031-30 |
| ndc | 82009-031-90 |
| code_info | Lot #: 240947C, 240962C, Exp. Date 04/2027 |
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-0215-2026%22
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