Duloxetine Delayed-Release Capsules — Class II drug recall D-0165-2025
Ongoing recall by RemedyRepack Inc., reported 2025-01-01, distributed nationwide. CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
| Recall number | D-0165-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RemedyRepack Inc., Indiana, PA, United States |
| Recall initiated | 2024-12-02 |
| Classified | 2024-12-26 |
| Reported by FDA | 2025-01-01 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, specification failure |
| NDC | 57237-0019-99, 70518-0937-03, 70518-0937-04 |
| Lot numbers | B3002625-060524, J0786744-061724 |
| Expiration dates | 2025-06-30, 2025-10-31 |
Product
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
Reason for recall
CGMP Deviations; presence of N-nitroso-duloxetine impurity above 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-0165-2025. 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.