Synjardy XR Tablets — Class II drug recall D-0657-2026
Ongoing recall by Boehringer Ingelheim Pharmaceuticals, Inc., reported 2026-07-08, distributed in OH. CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a product
| Recall number | D-0657-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, United States |
| Recall initiated | 2026-06-12 |
| Classified | 2026-06-30 |
| Reported by FDA | 2026-07-08 |
| Distributed | OH |
| Quantity | 560 bottles |
| Reason classes | cgmp |
| NDC | 00597-0300-45 |
| Lot numbers | 3244413 |
| Expiration dates | 2028-12-31 |
Product
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45
Reason for recall
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
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-0657-2026. 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.