DULOXETINE D/R — Class II drug recall D-0617-2026
Ongoing recall by Direct Rx, reported 2026-07-01, distributed nationwide. CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
| Recall number | D-0617-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Direct Rx, Dawsonville, GA, United States |
| Recall initiated | 2026-06-22 |
| Classified | 2026-06-23 |
| Reported by FDA | 2026-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 263 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 61919-0482-30, 61919-0482-60 |
| Lot numbers | 09DE2412, 09JA2528, 29JA2511 |
| Expiration dates | 2027-04-30 |
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 for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA 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-0617-2026. 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.