Duloxetine Delayed-Release Capsules — Class II drug recall D-0100-2025
Ongoing recall by Amerisource Health Services LLC, reported 2024-12-11, distributed in OH, PA, PR. CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
| Recall number | D-0100-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerisource Health Services LLC, Columbus, OH, United States |
| Recall initiated | 2024-11-14 |
| Classified | 2024-12-03 |
| Reported by FDA | 2024-12-11 |
| Distributed | OH, PA, PR |
| Quantity | 23,490 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 68001-0414-04, 68001-0414-08 |
| Lot numbers | DT3023019B, DT3023020A, DTB23098A |
| Expiration dates | 2025-01-31, 2025-08-31 |
Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
Reason for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the 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-0100-2025. 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.