FDA Drug recall D-0163-2025
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
- FDA Drug
- Class II
- terminated
- Published 2025-01-01
On 2025-01-01 the FDA classified a Class II recall of DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90 by Pd Rx Pharmaceuticals, citing CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0163-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-12-04 |
| Published | 2025-01-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pd Rx Pharmaceuticals |
| Distribution | FL, MS, WI |
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
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
Identifiers
| code_info | Lot # I24E77, A24E49, Exp Date: 04/30/25; J23C50, J23C97, L23B39, L23E98, Exp Date: 01/31/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0163-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.