Synjardy XR Tablets Recalled Due to Manufacturing Deviations
Boehringer Ingelheim Pharmaceuticals is recalling one lot of Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg due to manufacturing deviations involving incorrect detergent use and missing swab sampling.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving manufacturing deviations (CGMP violations). No illnesses or injuries have been reported, and the hazard is related to manufacturing process control rather than a confirmed contamination or labeling error affecting drug safety. This qualifies as a Moderate severity precautionary recall.
Plain-English summary
Boehringer Ingelheim Pharmaceuticals, Inc. is recalling Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 tablets per bottle, NDC 00597-0300-45, Lot 3244413 with an expiration date of 12/31/2028. The recall was initiated due to manufacturing deviations discovered during production.
The deviations involved the use of an incorrect detergent during production and the failure to perform required swab sampling on a production hopper that had previously been used for a different product. Approximately 560 bottles were affected and distributed in Ohio.
Patients taking this medication should contact their healthcare provider or pharmacist for further guidance. The medication should not be discontinued without consulting a healthcare professional.
The recalled product
- 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
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Affected units
- 560
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 3244413
- Exp. 12/31/2028
Distribution
Distributed in 1 state:
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