FDA Drug recall D-1112-2015
Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham…
- FDA Drug
- Class II
- terminated
- Published 2015-06-10
On 2015-06-10 the FDA classified a Class II recall of Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham… by Teva Pharmaceuticals Usa, citing failed Dissolution Specifications: OOS result during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1112-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-11 |
| Published | 2015-06-10 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
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
Failed Dissolution Specifications: OOS result during stability testing
Identifiers
| code_info | Lot #: 34019710A, Exp 5/2017 |
|---|
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-1112-2015%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.