CLASS II Drug recall · Reported 3 Oct 2018 · FDA Enforcement Report
Synjardy (empagliflozin and metformin hydrochloride) Tablets recalled
Boehringer Ingelheim Pharmaceuticals is recalling Synjardy (empagliflozin and metformin hydrochloride) Tablets, distributed nationwide in the US. The recall was initiated on 4 Sep 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1217-2018
- FDA event ID
- 80961
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT
- Brand
- Synjardy
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Sep 2018
- FDA classified
- 27 Sep 2018
- Reported
- 3 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Diabetes Medication
Timeline
| 4 Sep 2018 | Recall initiated by company | |
| 27 Sep 2018 | Classified by FDA | +23 days |
| 3 Oct 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross Contamination With Other Products:
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Cross Contamination With Other Products:
Which lots are affected?
Lot # 603968 EXP 4/2019
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Boehringer Ingelheim Pharmaceuticals
All 13Other Empagliflozin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Jardiance (empagliflozin tablets), 25 mg (3 blister cards with each) recalledJardiance | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Jardiance (Empagliflozin) recalled by Boehringer IngelheimJardiance | Boehringer Ingelheim Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Synjardy XR (empagliflozin and metformin hydrochloride recalledSynjardy | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg recalledGlyxambi | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Synjardy XR (empagliflozin and metformin) hydrochloride recalledSynjardy | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |