CLASS II Drug recall · Reported 22 Jul 2020 · FDA Enforcement Report
Auryxia (ferric citrate) tablets 210 mg recalled
Keryx Biopharmaceuticals is recalling Auryxia (ferric citrate) tablets 210 mg, distributed nationwide in the US. The recall was initiated on 10 Jul 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1389-2020
- FDA event ID
- 86008
- Recalling firm
- Keryx Biopharmaceuticals, Boston, MA
- Brand
- Auryxia
- Manufacturer
- Akebia Therapeutics, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jul 2020
- FDA classified
- 15 Jul 2020
- Reported
- 22 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 10 Jul 2020 | Recall initiated by company | |
| 15 Jul 2020 | Classified by FDA | +5 days |
| 22 Jul 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Which lots are affected?
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.
Where was it sold?
Nationwide in the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Keryx Biopharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Auryxia (ferric citrate) tablets, 210 mg recalledAuryxia | Keryx Biopharmaceuticals | Other | Nationwide |
Other Ferric recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Auryxia (ferric citrate) tablets 210 mg* recalled by Cardinal HealthAuryxia | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Auryxia (ferric citrate) tablets, 210 mg recalled by Akebia TherapeuticsAuryxia | Akebia Therapeutics | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Auryxia (ferric citrate) tablets, 210 mg recalledAuryxia | Keryx Biopharmaceuticals | Other | Nationwide |