FDA Drug recall D-1217-2018
Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg
- FDA Drug
- Class II
- terminated
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class II recall of Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg by Boehringer Ingelheim Pharmaceuticals, citing cross Contamination With Other Products:.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1217-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-04 |
| Published | 2018-10-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Boehringer Ingelheim Pharmaceuticals |
| Distribution | US |
Product
Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: Boehinger Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877. Made in Germany. Marketed by: BI Pharmaceuticals, Inc. Ridgefield, CT 06877 and Eli Lilly and Company Indianapolis IN 46285 NDC 0597-0175-18
Reason
Cross Contamination With Other Products:
Identifiers
| ndc | 0597-0159-60 |
|---|---|
| ndc | 0597-0159-18 |
| ndc | 0597-0159-66 |
| ndc | 0597-0175-60 |
| ndc | 0597-0175-18 |
| ndc | 0597-0175-66 |
| ndc | 0597-0180-60 |
| ndc | 0597-0180-18 |
| ndc | 0597-0180-66 |
| ndc | 0597-0168-60 |
| ndc | 0597-0168-18 |
| ndc | 0597-0168-66 |
| code_info | Lot # 603968 EXP 4/2019 |
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-1217-2018%22
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