Auryxia Tablets Recalled for Failed Dissolution Specifications
Akebia Therapeutics is recalling Auryxia (ferric citrate) tablets because they failed to meet dissolution specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which indicates a remote possibility of adverse health consequences. The hazard is a quality control failure (dissolution) without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Akebia Therapeutics dba Keryx Biopharmaceuticals, Inc. is recalling Auryxia (ferric citrate) tablets, 210 mg, 200 tablets per bottle. The recall affects 17,664 bottles distributed nationwide. The specific lots involved are CDKSN and CDPPH with an expiration date of January 2022, and lot CDPPK with an expiration date of February 2022.
The recall was initiated because the product failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the medication breaks down properly in the body to be absorbed. When this specification is not met, the medication may not work as intended.
Consumers and healthcare providers should stop using the affected Auryxia tablets and contact their healthcare provider for guidance. The product is prescription-only (RX ONLY).
The recalled product
- Product
- Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 17,664
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 (5)
- Lots #: CDKSN
- CDPPH
- Exp January 2022
- Lot #: CDPPK
- Exp February 2022.
Distribution
Distributed nationwide across the United States.
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FDA (Drugs) · 2020-12-30
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