CLASS II Drug recall · Reported 30 Dec 2020 · FDA Enforcement Report
Auryxia (ferric citrate) tablets, 210 mg recalled by Akebia Therapeutics
Akebia Therapeutics is recalling Auryxia (ferric citrate) tablets, 210 mg, distributed nationwide in the US. The recall was initiated on 9 Dec 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-0170-2021
- FDA event ID
- 86955
- Recalling firm
- Akebia Therapeutics, Cambridge, MA
- Brand
- Auryxia
- Manufacturer
- Akebia Therapeutics, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Dec 2020
- FDA classified
- 18 Dec 2020
- Reported
- 30 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 9 Dec 2020 | Recall initiated by company | |
| 18 Dec 2020 | Classified by FDA | +9 days |
| 30 Dec 2020 | Published in enforcement report | +12 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
Product as listed by the FDA
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
Where it was distributed
The product was distributed by two major distributors who further distributed the product nationwide and one specialty pharmacy.
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot Number: 9062, exp. date Feb 2021
Where was it sold?
The product was distributed by two major distributors who further distributed the product nationwide and one specialty pharmacy.
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 Akebia Therapeutics
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Auryxia (ferric citrate) tablets, 210 mg* recalled | Akebia Therapeutics | Potency & Assay | 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 recalledAuryxia | Keryx Biopharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Auryxia (ferric citrate) tablets, 210 mg recalledAuryxia | Keryx Biopharmaceuticals | Other | Nationwide |