FDA Recalls Jardiance Diabetes Tablets Due to Storage Temperature Deviations
Jardiance 25 mg tablets distributed nationwide were recalled due to CGMP deviations where products were exposed to temperatures outside the labeled storage conditions. The recall affects batch D41919.
What this means for you
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 a voluntary precautionary recall related to a manufacturing practice deviation. FDA Class II recalls without confirmed product failure or reported patient harm are classified as Moderate per the recall severity rubric.
Plain-English summary
Jardiance (empagliflozin) 25 mg tablets, 30-tablet packs, have been recalled nationwide due to Current Good Manufacturing Practice (CGMP) deviations. According to the recall, products were exposed to temperatures outside the labeled storage conditions, which affects pharmaceutical stability and product quality.
The recall applies to batch D41919 (NDC 0597-0153-37), distributed throughout the United States. Jardiance is manufactured and distributed by Boehringer Ingelheim Pharmaceuticals, Inc., and is indicated as a prescription medication for diabetes management.
Patients taking this medication should contact their pharmacy or healthcare provider regarding the recall and potential next steps.
The recalled product
- Product
- JARDIANCE (EMPAGLIFLOZIN)
- Brand
- JARDIANCE
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug
- Hazard
- improper-storage
- temperature-exposure
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 (1)
- Batch D41919
Distribution
Distributed nationwide across the United States.
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