FDA Drug recall D-0181-2016
Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spa…
- FDA Drug
- Class III
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class III recall of Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spa… by Breckenridge Pharmaceutical, citing presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0181-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-10-21 |
| Published | 2015-11-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Breckenridge Pharmaceutical |
| Distribution | US |
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
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Identifiers
| ndc | 51991-746-06 |
|---|---|
| ndc | 51991-746-90 |
| ndc | 51991-746-05 |
| ndc | 51991-747-33 |
| ndc | 51991-747-90 |
| ndc | 51991-747-10 |
| ndc | 51991-748-33 |
| ndc | 51991-748-90 |
| ndc | 51991-748-10 |
| ndc | 51991-750-33 |
| ndc | 51991-750-90 |
| ndc | 51991-750-05 |
| ndc | 51991-750-10 |
| code_info | Lot #: 142391, Exp 10/2016 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0181-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.