FDA Drug recall D-0983-2017
Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc.,…
- FDA Drug
- Class III
- terminated
- Published 2017-07-26
On 2017-07-26 the FDA classified a Class III recall of Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc.,… by Teva Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0983-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-06-29 |
| Published | 2017-07-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56
Reason
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Identifiers
| code_info | Lot #: 30227613A, 30227614A, 30227615A, EXP 6/2017; 30228559A, 30228560A, EXP 9/2017; 3000123, EXP 7/2018 |
|---|
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-0983-2017%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.