Duloxetine Delayed-Release Capsules — Class II drug recall D-0216-2026
Ongoing recall by Breckenridge Pharmaceutical, Inc., reported 2025-12-10, distributed nationwide. CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
| Recall number | D-0216-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ, United States |
| Recall initiated | 2025-11-24 |
| Classified | 2025-12-03 |
| Reported by FDA | 2025-12-10 |
| Distributed | Nationwide (US) |
| Quantity | 7,389 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 51991-0746, 51991-0746-05, 51991-0746-06, 51991-0746-90, 51991-0747, 51991-0747-10, 51991-0747-33, 51991-0747-90, 51991-0748, 51991-0748-10, 51991-0748-33, 51991-0748-90, 51991-0750, 51991-0750-05, 51991-0750-10, 51991-0750-33, 51991-0750-90 |
| Lot numbers | 240534C, 240977C |
| Expiration dates | 2027-01, 2027-04 |
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
Reason for recall
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0216-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.