FDAFDA recall D-0657-2026 · Jul 8, 2026
Boehringer Ingelheim Pharmaceuticals, Inc.: Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets) recall
Recall found
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot 3244413; Exp. 12/31/2028
- Quantity
- 560 bottles
- Distribution
- OH
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-12
Source: openFDA enforcement record D-0657-2026 · search recall number D-0657-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.