The Recall Desk
ModerateFDA (Drugs)·D-0436-2021·Announced 2021-06-02

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.

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, 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
Hazard
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

Distributed in 3 states:

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.

See all 198 products in this recall →

Related recalls

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Same hazard · temperature excursion

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