Class IIOngoing
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets) recall
FDA recall D-0657-2026 · initiated Jun 12, 2026
By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Jul 8, 2026How we research
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.
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?
- Distribution: OH. The affected lot numbers and expiration dates are listed in the official FDA enforcement record for recall D-0657-2026, initiated Jun 2026.