Duloxetine Delayed-Release Capsules — Class II drug recall D-0580-2025
Ongoing recall by Breckenridge Pharmaceutical, Inc., reported 2025-08-20, distributed in AZ, IN, NJ. CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
| Recall number | D-0580-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ, United States |
| Recall initiated | 2025-07-25 |
| Classified | 2025-08-12 |
| Reported by FDA | 2025-08-20 |
| Distributed | AZ, IN, NJ |
| Quantity | 1,856 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 82009-0029, 82009-0029-05, 82009-0030, 82009-0030-10, 82009-0031, 82009-0031-30, 82009-0031-90, 82009-0032, 82009-0032-10 |
| Lot numbers | 240539C |
| Expiration dates | 2027-01-31 |
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 for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim 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-0580-2025. 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.