FDA Drug recall D-0522-2026
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona),…
- FDA Drug
- Class II
- ongoing
- Published 2026-05-13
On 2026-05-13 the FDA classified a Class II recall of Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona),… 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-0522-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-21 |
| Published | 2026-05-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Breckenridge Pharmaceutical |
| Distribution | US |
Product
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
Reason
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended 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: 241069C, Exp 05/31/2027 |
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, 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 - Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only,…
FDA Drug · Class II · 2025-11-05 · Breckenridge Pharmaceutical
All Breckenridge Pharmaceutical recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0522-2026%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.