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 210 mg Recalled by Keryx Biopharmaceuticals, Inc. Due to cGMP deviations: Lots recalled were not manufactured in...

Date: July 10, 2020
Company: Keryx Biopharmaceuticals, 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 Keryx Biopharmaceuticals, Inc. directly.

Affected Products

Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc., 245 First Street Suite 1400, Cambridge, MA 02142, NDC: 59922-631-01.

Quantity: 59,820 bottles

Why Was This Recalled?

cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

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