Auryxia — Class II drug recall D-0170-2021
Terminated recall by Akebia Therapeutics dba Keryx Biopharmaceutials, Inc, reported 2020-12-30, distributed nationwide. CGMP Deviations
| Recall number | D-0170-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akebia Therapeutics dba Keryx Biopharmaceutials, Inc, Cambridge, MA, United States |
| Recall initiated | 2020-12-09 |
| Classified | 2020-12-18 |
| Reported by FDA | 2020-12-30 |
| Terminated | 2021-09-01 |
| Distributed | Nationwide (US) |
| Quantity | 2,170 bottles |
| Reason classes | cgmp |
| NDC | 59922-0631, 59922-0631-01 |
| Lot numbers | 9062 |
| Expiration dates | 2021-02-20 |
Product
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
Reason for recall
CGMP Deviations
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0170-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.