Buprenorphine and Naloxone Sublingual Tablets — Class III drug recall D-0983-2017
Terminated recall by Teva Pharmaceuticals USA, reported 2017-07-26, distributed nationwide. Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest
| Recall number | D-0983-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2017-06-29 |
| Classified | 2017-07-14 |
| Reported by FDA | 2017-07-26 |
| Terminated | 2018-04-26 |
| Distributed | Nationwide (US) |
| Quantity | 25,264 bottles |
| Reason classes | specification failure |
| NDC | 00093-5720-56 |
| Lot numbers | 3000123, 30227613A, 30227614A, 30227615A, 30228559A, 30228560A |
| Expiration dates | 2017-06, 2017-09, 2018-07 |
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 for recall
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
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-0983-2017. 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.