Duloxetine Delayed-Release Capsules — Class II drug recall D-1183-2014
Terminated recall by Teva Pharmaceuticals USA, reported 2014-04-09, distributed nationwide. Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Dulox
| Recall number | D-1183-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Horsham, PA, United States |
| Recall initiated | 2014-03-04 |
| Classified | 2014-04-01 |
| Reported by FDA | 2014-04-09 |
| Terminated | 2014-11-12 |
| Distributed | Nationwide (US) |
| Quantity | 598,033 bottles |
| Reason classes | device malfunction |
| NDC | 00093-7543-56 |
| Lot numbers | 49D001, 49D002, 49D003, 49D004, 49D005, 49D006, 49D007 |
| Expiration dates | 2015-04, 2015-06, 2015-07, 2015-09, 2015-10 |
Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7543-56
Reason for recall
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.
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-1183-2014. 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.