Synjardy — Class II drug recall D-1217-2018
Terminated recall by Boehringer Ingelheim Pharmaceuticals, Inc., reported 2018-10-03, distributed nationwide. Cross Contamination With Other Products:
| Recall number | D-1217-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, United States |
| Recall initiated | 2018-09-04 |
| Classified | 2018-09-27 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2019-08-19 |
| Distributed | Nationwide (US) |
| NDC | 00597-0159, 00597-0159-18, 00597-0159-60, 00597-0159-66, 00597-0168, 00597-0168-18, 00597-0168-60, 00597-0168-66, 00597-0175, 00597-0175-18, 00597-0175-60, 00597-0175-66, 00597-0180, 00597-0180-18, 00597-0180-60, 00597-0180-66 |
| Lot numbers | 603968 |
| Expiration dates | 2019-04 |
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 for recall
Cross Contamination With Other Products:
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-1217-2018. 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.