Cardinal Health Recalls XIGDUO Tablets Due to Temperature Excursions
Cardinal Health is recalling 378 bottles of XIGDUO tablets due to intermittent exposure to temperature excursions during storage.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a CGMP deviation (temperature excursion) without reported harm, which aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls where no adverse events are documented.
Plain-English summary
Cardinal Health Inc. is recalling 378 bottles of XIGDUO (dapagliflozin and metformin hydrochloride) extended-release tablets. The specific product affected is the 5 mg/1000 mg strength, packaged in bottles of 60 tablets (NDC 0310-6260-60). The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.
The affected product was distributed in Florida, Georgia, and South Carolina. The lot code for the recalled product is ML0171. XIGDUO is a prescription medication manufactured for AstraZeneca Pharmaceuticals LP.
Consumers who have this specific product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- XIGDUO (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE)
- Brand
- XIGDUO
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 378
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)
- ML0171
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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