FDA Drug recall D-0457-2021
Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1000 mg 30 tablets Rx only NDC 0597-0275-33 Dist. by:…
- FDA Drug
- Class II
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class II recall of Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1000 mg 30 tablets Rx only NDC 0597-0275-33 Dist. by:… by Cardinal Health, citing CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0457-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-15 |
| Published | 2021-06-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Health |
| Distribution | FL, GA, SC |
Product
Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1000 mg 30 tablets Rx only NDC 0597-0275-33 Dist. by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA
Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Identifiers
| ndc | 0597-0270-12 |
|---|---|
| ndc | 0597-0270-73 |
| ndc | 0597-0270-94 |
| ndc | 0597-0275-33 |
| ndc | 0597-0275-81 |
| ndc | 0597-0275-88 |
| code_info | 3189866 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0457-2021%22
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