FDA Drug recall D-0277-2025
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, N…
- FDA Drug
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, N… by Rising Pharma Holding, citing CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0277-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-05 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Rising Pharma Holding |
| Distribution | US |
Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Identifiers
| code_info | Lot #: DTB23111A, Exp 8/31/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0277-2025%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.