Duloxetine Delayed-release Capsules — Class III drug recall D-0181-2016
Terminated recall by Breckenridge Pharmaceutical, Inc, reported 2015-11-18, distributed nationwide. Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bott
| Recall number | D-0181-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Breckenridge Pharmaceutical, Inc, Berlin, CT, United States |
| Recall initiated | 2015-10-21 |
| Classified | 2015-11-10 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2015-12-24 |
| Distributed | Nationwide (US) |
| Quantity | 595 bottles |
| NDC | 51991-0746, 51991-0746-05, 51991-0746-06, 51991-0746-90, 51991-0747, 51991-0747-10, 51991-0747-33, 51991-0747-90, 51991-0748, 51991-0748-10, 51991-0748-33, 51991-0748-90, 51991-0750, 51991-0750-05, 51991-0750-10, 51991-0750-33, 51991-0750-90 |
| Lot numbers | 142391 |
| Expiration dates | 2016-10 |
Product
Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10
Reason for recall
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
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-0181-2016. 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.