CLASS III Drug recall · Reported 3 Jan 2018 · 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 12 Dec 2017 and the FDA has classified it as Class III.
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-0133-2018
- FDA event ID
- 78773
- Recalling firm
- Keryx Biopharmaceuticals, Boston, MA
- Brand
- Auryxia
- Manufacturer
- Akebia Therapeutics, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Dec 2017
- FDA classified
- 26 Dec 2017
- Reported
- 3 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 12 Dec 2017 | Recall initiated by company | |
| 26 Dec 2017 | Classified by FDA | +14 days |
| 3 Jan 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
Product as listed by the FDA
Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Biopharmaceticals, Inc. One Marina Park Drive, 12th Floor, Boston, MA 02210 USA. NDC 59922-631-01
Where it was distributed
Distributed nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
Which lots are affected?
Lot # AH3842
Where was it sold?
Distributed nationwide in the USA
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 II | Auryxia (ferric citrate) tablets 210 mg recalledAuryxia | Keryx Biopharmaceuticals | Manufacturing (CGMP) Deviations | 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 II | Auryxia (ferric citrate) tablets 210 mg recalledAuryxia | Keryx Biopharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |