Kombiglyze XR — Class II drug recall D-019-2013
Terminated recall by Bristol-myers Squibb Company, reported 2012-10-31, distributed nationwide. Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as K
| Recall number | D-019-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bristol-myers Squibb Company, New Brunswick, NJ, United States |
| Recall initiated | 2012-06-05 |
| Classified | 2012-10-24 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2013-07-10 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | 09/13, 10/13, 11/13, 1J6024PA, 1J6025PA, 1K6049PA, 1L9015WA |
Product
Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 7 Tablets per Carton, 5 mg/500 mg, Rx only, Manufactured By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA, Marketed By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA and AstraZeneca Pharmaceuticals LP, Wilmington DE 19850.
Reason for recall
Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.
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-019-2013. 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.