Duloxetine Delayed-Release Capsules USP — Class III drug recall D-0097-2018
Terminated recall by Lupin Pharmaceuticals Inc., reported 2017-12-06, distributed nationwide. Failed Dissolution Specification
| Recall number | D-0097-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2017-11-21 |
| Classified | 2017-11-28 |
| Reported by FDA | 2017-12-06 |
| Terminated | 2019-04-15 |
| Distributed | Nationwide (US) |
| Quantity | 111,648 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00368180295068 |
| NDC | 68180-0294, 68180-0294-03, 68180-0294-06, 68180-0294-07, 68180-0294-09, 68180-0295, 68180-0295-03, 68180-0295-06, 68180-0295-09, 68180-0296, 68180-0296-03, 68180-0296-06, 68180-0296-09, 68180-0297, 68180-0297-03, 68180-0297-06, 68180-0297-09 |
| Lot numbers | G602051 |
| Expiration dates | 2017-12 |
Product
Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403 722 India, NDC 68180-295-06, UPC 368180295068
Reason for recall
Failed Dissolution Specification
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-0097-2018. 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.