FDAHealthJune 12, 2026
Boehringer Ingelheim Pharmaceuticals, Inc. — Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boe
⚠️ 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 this relevant to me?
- Geography
- OH
- Source agency
- FDA
- Category
- Health
- Published
- June 12, 2026
OH
What's affected?
- 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
- Lot code
- 3244413
Additional details
Lot 3244413; Exp. 12/31/2028
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 560 bottles.
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