FDA Drug recall D-0580-2025
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Mar…
- FDA Drug
- Class II
- ongoing
- Published 2025-08-20
On 2025-08-20 the FDA classified a Class II recall of Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Mar… 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-0580-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-25 |
| Published | 2025-08-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Breckenridge Pharmaceutical |
| Distribution | AZ, IN, NJ |
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim 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 240539C, Exp 1/31/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Breckenridge Pharmaceutical
- Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorell…
FDA Drug · Class II · 2026-06-17 · Breckenridge Pharmaceutical - Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90)
FDA Drug · Class II · 2026-06-17 · Breckenridge Pharmaceutical - Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona),…
FDA Drug · Class II · 2026-05-13 · Breckenridge Pharmaceutical - Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrel…
FDA Drug · Class II · 2025-12-10 · Breckenridge Pharmaceutical - Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrel…
FDA Drug · Class II · 2025-12-10 · Breckenridge Pharmaceutical
All Breckenridge Pharmaceutical recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0580-2025%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.