DULoxetine DR USP — Class II drug recall D-0163-2025
Terminated recall by PD-Rx Pharmaceuticals, Inc., reported 2025-01-01, distributed in FL, MS, WI. CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine a
| Recall number | D-0163-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK, United States |
| Recall initiated | 2024-12-04 |
| Classified | 2024-12-23 |
| Reported by FDA | 2025-01-01 |
| Terminated | 2025-03-21 |
| Distributed | FL, MS, WI |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 43063-0877-90 |
| Lot numbers | A24E49, I24E77, J23C50, J23C97, L23B39, L23E98 |
| Expiration dates | 2025-01-31, 2025-04-30 |
Product
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
Reason for recall
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake 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-0163-2025. 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.