Auryxia — Class III drug recall D-0260-2021
Terminated recall by Akebia Therapeutics dba Keryx Biopharmaceutials, Inc, reported 2021-02-24, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0260-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akebia Therapeutics dba Keryx Biopharmaceutials, Inc, Cambridge, MA, United States |
| Recall initiated | 2021-01-29 |
| Classified | 2021-02-17 |
| Reported by FDA | 2021-02-24 |
| Terminated | 2022-02-10 |
| Distributed | Nationwide (US) |
| Quantity | 17,664 bottles |
| Reason classes | specification failure |
| NDC | 59922-0631-01 |
| Expiration dates | 2022-01-20, 2022-02-20 |
Product
Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01.
Reason for recall
Failed Dissolution Specifications
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-0260-2021. 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.