BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets — Class II drug recall D-1324-2014
Terminated recall by Teva Pharmaceuticals USA, reported 2014-05-28, distributed nationwide. Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained du
| Recall number | D-1324-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2014-04-07 |
| Classified | 2014-05-16 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2014-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 17,181 bottles |
| Reason classes | specification failure |
| NDC | 00093-5378-56 |
| Lot numbers | 11/14, 34013132A, 34013133A, 34013134A, 34013135A, 34013136A |
Product
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5.
Reason for recall
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
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-1324-2014. 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.