Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release recall
FDA recall D-0657-2026 · initiated Jun 12, 2026
Boehringer Ingelheim Pharmaceuticals, Inc. recalled Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release in Jun 2026 — an FDA Class II recall (D-0657-2026) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was 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.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 560 bottles
Details
- 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
- Recalling company
- Boehringer Ingelheim Pharmaceuticals Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- OH
- Initiated
- Jun 12, 2026
- FDA report date
- Jul 8, 2026
Frequently asked
- Was Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release recalled?
- Boehringer Ingelheim Pharmaceuticals, Inc. recalled Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release in Jun 2026 — an FDA Class II recall (D-0657-2026) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release recalled?
- Per the FDA enforcement record, the reason for recall D-0657-2026 was: 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.
- Is a recalled Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release are affected?
- Distributed: OH. The recall covers these lots — Lot 3244413; Exp. 12/31/2028. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0657-2026.