Cardinal Health Recalls XIGDUO Tablets Due to Temperature Excursions
Cardinal Health is recalling 664 bottles of XIGDUO tablets because of intermittent temperature exposure during storage. The affected products were distributed in Florida, Georgia, and South Carolina.
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: The recall is classified as FDA Class II and involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 664 bottles of XIGDUO (dapagliflozin and metformin hydrochloride) extended-release tablets, 10 mg/1000 mg, 30-count bottles. The recall is due to current good manufacturing practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.
The affected product is identified by lot code MP0077 and NDC 0310-6280-30. The medication was manufactured for AstraZeneca Pharmaceuticals LP and by Bristol-Myers Squibb Manufacturing Company. Distribution was limited to Florida, Georgia, and South Carolina.
Consumers who have this specific lot of XIGDUO should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or further instructions.
The recalled product
- Product
- XIGDUO (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE)
- Brand
- XIGDUO
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 664
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)
- MP0077
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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