Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Auryxia (ferric citrate) tablets Recalled by Akebia Therapeutics dba Keryx Biopharmaceutials, Inc Due to Failed Dissolution Specifications

Date: January 29, 2021
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 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.

Quantity: 17,664 bottles

Why Was This Recalled?

Failed Dissolution Specifications

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.

Related Recalls

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