CLASS II ONGOING Drug recall · Reported 8 Jul 2026 · FDA Enforcement Report
Synjardy XR Tablets (empagliflozin recalled by Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals is recalling Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), distributed in Ohio. The recall was initiated on 12 Jun 2026 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-0657-2026
- FDA event ID
- 99233
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Jun 2026
- FDA classified
- 30 Jun 2026
- Reported
- 8 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Diabetes Medication
Timeline
| 12 Jun 2026 | Recall initiated by company | |
| 30 Jun 2026 | Classified by FDA | +18 days |
| 8 Jul 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
OH
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot 3244413; Exp. 12/31/2028
Where was it sold?
OH
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 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Jardiance (Empagliflozin) recalled by Boehringer IngelheimJardiance | Boehringer Ingelheim Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Micardis Tablets, (telmisartan Tablets) 80 mg per folding recalled | Boehringer Ingelheim Pharmaceuticals | Potency & Assay | 11 states |
| Drug | CLASS II | Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet recalled | Boehringer Ingelheim Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet recalled | Boehringer Ingelheim Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet recalled | Boehringer Ingelheim Pharmaceuticals | Foreign Material | Nationwide |
Other Synjardy (empagliflozin recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Synjardy (empagliflozin and metformin hydrochloride) recalled | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |