Cardinal Health Recalls Glyxambi Tablets Due to Temperature Excursions
Cardinal Health is recalling 592 bottles of Glyxambi tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
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: The recall is classified as FDA Class II, and the hazard involves storage conditions (temperature excursions) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 592 bottles of Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg, 30 tablets per bottle. The recall is due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. The product is distributed by Boehringer Ingelheim Pharmaceuticals, Inc.
The affected product is identified by lot code 3513 and NDC 0597-0164-30. Distribution was limited to Florida, Georgia, and South Carolina.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on replacement or further instructions.
The recalled product
- Product
- GLYXAMBI (EMPAGLIFLOZIN AND LINAGLIPTIN)
- Brand
- GLYXAMBI
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 592
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)
- 3513
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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