FDA Drug recall D-0617-2026
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps
- FDA Drug
- Class II
- ongoing
- Published 2026-07-01
On 2026-07-01 the FDA classified a Class II recall of DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps by Direct Rx, citing CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0617-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-22 |
| Published | 2026-07-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Direct Rx |
| Distribution | US |
Product
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Identifiers
| code_info | Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027. |
|---|
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-0617-2026%22
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