FDA Drug recall D-0260-2021
Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC.…
- FDA Drug
- Class III
- terminated
- Published 2021-02-24
On 2021-02-24 the FDA classified a Class III recall of Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC.… by Akebia Therapeutics, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0260-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-01-29 |
| Published | 2021-02-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akebia Therapeutics |
| Distribution | US |
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
Failed Dissolution Specifications
Identifiers
| code_info | Lots #: CDKSN, CDPPH, Exp January 2022; Lot #: CDPPK, Exp February 2022. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0260-2021%22
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