Duloxetine D/R — Class II drug recall D-0568-2025
Ongoing recall by Direct Rx, reported 2025-08-13, distributed nationwide. CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
| Recall number | D-0568-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Direct Rx, Dawsonville, GA, United States |
| Recall initiated | 2025-03-07 |
| Classified | 2025-08-04 |
| Reported by FDA | 2025-08-13 |
| Distributed | Nationwide (US) |
| Quantity | 875 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 61919-0482-30, 61919-0482-60, 61919-0482-90 |
| Expiration dates | 2026-01-31, 2027-01-31, 2027-03-31 |
Product
Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,
Reason for recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed 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-0568-2025. 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.