Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Auryxia (ferric citrate) tablets Recalled by Akebia Therapeutics dba Keryx Biopharmaceutials, Inc Due to CGMP Deviations

Date: December 9, 2020
Company: Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Akebia Therapeutics dba Keryx Biopharmaceutials, Inc directly.

Affected Products

Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., One Marina Park Drive, 12th Floor, Boston, MA 02210, NDC 59922-631-01

Quantity: 2,170 bottles

Why Was This Recalled?

CGMP Deviations

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

Akebia Therapeutics dba Keryx Biopharmaceutials, Inc has 2 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report