The Recall Desk
ModerateFDA (Drugs)·D-0499-2021·Announced 2021-06-02

Cardinal Health Recalls Auryxia Tablets Due to Temperature Excursions

Cardinal Health is recalling 136 bottles of Auryxia (ferric citrate) 210 mg 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a CGMP deviation (temperature excursion) without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary measures.

Plain-English summary

Cardinal Health Inc. is recalling 136 bottles of Auryxia (ferric citrate) 210 mg tablets, NDC 59922-631-01. The recall was initiated because the product experienced intermittent exposure to temperature excursions during storage, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.

The affected product is a prescription-only oral medication manufactured for and distributed by Keryx Biopharmaceuticals, Inc. The specific lot code for the recalled items is AN0142D. The recall is limited to 136 bottles that were distributed in Florida, Georgia, and South Carolina.

Consumers and healthcare providers should check their inventory for Auryxia tablets with lot code AN0142D. If found, the product should be discontinued and returned to the pharmacy or distributor for credit. Patients should consult their healthcare provider for alternative treatment options if they have been using the recalled product.

The recalled product

Product
AURYXIA (FERRIC CITRATE)
Brand
AURYXIA
Manufacturer
Cardinal Health Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
136

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)

  • AN0142D

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

Same brand · AURYXIA

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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