Auryxia Tablets (Keryx Biopharmaceuticals) – Manufacturing Deviation (2020)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Keryx Biopharmaceuticals, Inc.
Lot Codes / Batch Numbers
Lot #s: AK6003C, Exp. 10/31/2020, AK6004B, Exp. 11/30/2020, CBMKF, CBMKH, Exp. 08/31/2020, CCKSM, Exp. 09/30/2020, CBWKN, Exp. 11/30/2020, CCSTZ, CCWZB, Exp. 05/31/2021, CCYSF, CCYSG, CCWZC, Exp. 06/30/2021, CDCTB, CDCSZ, Exp. 07/31/2021.
Products Sold
Lot #s: AK6003C, Exp. 10/31/2020; AK6004B, Exp. 11/30/2020; CBMKF, CBMKH, Exp. 08/31/2020; CCKSM, Exp. 09/30/2020; CBWKN, Exp. 11/30/2020; CCSTZ, CCWZB, Exp. 05/31/2021; CCYSF, CCYSG, CCWZC, Exp. 06/30/2021; CDCTB, CDCSZ, Exp. 07/31/2021.
Keryx Biopharmaceuticals, Inc. is recalling Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distr due to cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026