Zebeta¿ — Class II drug recall D-1112-2015
Terminated recall by Teva Pharmaceuticals USA, reported 2015-06-10, distributed nationwide. Failed Dissolution Specifications: OOS result during stability testing
| Recall number | D-1112-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Horsham, PA, United States |
| Recall initiated | 2015-05-11 |
| Classified | 2015-06-01 |
| Reported by FDA | 2015-06-10 |
| Terminated | 2016-11-08 |
| Distributed | Nationwide (US) |
| Quantity | 889 bottles |
| Reason classes | specification failure |
| NDC | 51285-0061-01 |
| Lot numbers | 34019710A |
| Expiration dates | 2017-05 |
Product
Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01
Reason for recall
Failed Dissolution Specifications: OOS result 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-1112-2015. 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.