Duloxetine Delayed-Release Capsules USP 30 mg — Class II drug recall D-0188-2025
Ongoing recall by Rising Pharma Holding, Inc., reported 2025-01-15, distributed nationwide. CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
| Recall number | D-0188-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Rising Pharma Holding, Inc., East Brunswick, NJ, United States |
| Recall initiated | 2024-12-30 |
| Classified | 2025-01-08 |
| Reported by FDA | 2025-01-15 |
| Distributed | Nationwide (US) |
| Quantity | 42,527 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 57237-0018-30, 57237-0018-99 |
| Lot numbers | APR-25, DT3023051A |
Product
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
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-0188-2025. 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.