Duloxetine DR Capsules — Class II drug recall D-0555-2026
Ongoing recall by Asclemed USA Inc., reported 2026-06-10, distributed nationwide. CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above
| Recall number | D-0555-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Asclemed USA Inc., Torrance, CA, United States |
| Recall initiated | 2026-05-14 |
| Classified | 2026-06-02 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 50 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 76420-0623, 76420-0623-00, 76420-0623-01, 76420-0623-20, 76420-0623-30, 76420-0623-60, 76420-0623-90, 76420-0633, 76420-0633-00, 76420-0633-01, 76420-0633-05, 76420-0633-20, 76420-0633-30, 76420-0633-60, 76420-0633-90, 76420-0634, 76420-0634-00, 76420-0634-01, 76420-0634-20, 76420-0634-30, 76420-0634-60, 76420-0634-90, 76420-0636, 76420-0636-01, 76420-0636-20 and 3 more |
| Lot numbers | 050725F-30, 050725G-30 |
| Expiration dates | 2026-06-30 |
Product
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
Reason for recall
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake 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-0555-2026. 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.