The Recall Desk
ModerateFDA (Drugs)·D-1389-2020·Announced 2020-07-22

Keryx Recalls Auryxia Tablets Due to Manufacturing Process Deviations

Keryx Biopharmaceuticals is recalling 59,820 bottles of Auryxia (ferric citrate) tablets because they were not manufactured in conformance with the FDA-approved process.

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 might cause temporary or medically reversible adverse health consequences. The source text does not report any specific illnesses, injuries, or fatalities, and the hazard is a manufacturing deviation rather than a confirmed contamination or defect causing immediate harm.

Plain-English summary

Keryx Biopharmaceuticals, Inc. is recalling 59,820 bottles of Auryxia (ferric citrate) tablets, 210 mg, 200 tablets per bottle. The product is distributed nationwide in the U.S. The recall involves specific lots with expiration dates ranging from May 2021 to October 2020, including lot numbers AK6003C, AK6004B, CBMKF, CBMKH, CCKSM, CBWKN, CCSTZ, CCWZB, CCYSF, CCYSG, CCWZC, CDCTB, and CDCSZ.

The recall was initiated because the lots were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia. This constitutes a Current Good Manufacturing Practice (cGMP) deviation. The agency has classified this as a Class II recall.

Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or the manufacturer for further instructions. The recall is limited to the specific lot numbers and expiration dates listed above.

The recalled product

Product
AURYXIA (FERRIC CITRATE)
Brand
AURYXIA
Manufacturer
Keryx Biopharmaceuticals, Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
59,820

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 (20)

  • Lot #s: AK6003C
  • Exp. 10/31/2020
  • AK6004B
  • Exp. 11/30/2020
  • CBMKF
  • CBMKH
  • Exp. 08/31/2020
  • CCKSM
  • Exp. 09/30/2020
  • CBWKN
  • CCSTZ
  • CCWZB
  • Exp. 05/31/2021
  • CCYSF
  • CCYSG
  • CCWZC
  • Exp. 06/30/2021
  • CDCTB
  • CDCSZ
  • Exp. 07/31/2021.

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · AURYXIA

Same hazard · cGMP deviation

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