FDA Drug recall D-0458-2021
Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets Rx only NDC 0597-0295-88 Dist. by…
- FDA Drug
- Class II
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class II recall of Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets Rx only NDC 0597-0295-88 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-0458-2021 |
| 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
Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets Rx only NDC 0597-0295-88 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA
Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Identifiers
| ndc | 0597-0280-36 |
|---|---|
| ndc | 0597-0280-73 |
| ndc | 0597-0280-90 |
| ndc | 0597-0290-20 |
| ndc | 0597-0290-59 |
| ndc | 0597-0290-74 |
| ndc | 0597-0295-61 |
| ndc | 0597-0295-78 |
| ndc | 0597-0295-88 |
| ndc | 0597-0300-20 |
| ndc | 0597-0300-45 |
| ndc | 0597-0300-93 |
| code_info | 3191432 |
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-0458-2021%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.