Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles — Class II drug recall D-0224-2017
Terminated recall by Inventia Healthcare Private Limited, reported 2016-12-28. Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated o
| Recall number | D-0224-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inventia Healthcare Private Limited, Thane, N/A, India |
| Recall initiated | 2016-10-19 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-06-01 |
| Quantity | 46,848 delayed |
| NDC | 69097-0298-02 |
| Lot numbers | 10/17, 130/16/001, 130/16/002, 130/16/003 |
Product
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA, Distributed by: Cipia USA, Inc., Miami, FL 33156, NDC 69097-298-02
Reason for recall
Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
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-0224-2017. 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.