Auryxia — Class II drug recall D-1389-2020
Terminated recall by Keryx Biopharmaceuticals, Inc., reported 2020-07-22, distributed nationwide. cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing proces
| Recall number | D-1389-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Keryx Biopharmaceuticals, Inc., Boston, MA, United States |
| Recall initiated | 2020-07-10 |
| Classified | 2020-07-15 |
| Reported by FDA | 2020-07-22 |
| Terminated | 2021-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 59,820 bottles |
| Reason classes | cgmp |
| NDC | 59922-0631, 59922-0631-01 |
| Lot numbers | AK6003C, AK6004B |
| Expiration dates | 2020-08-31, 2020-09-30, 2020-10-31, 2020-11-30, 2021-05-31, 2021-06-30, 2021-07-31 |
Product
Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc., 245 First Street Suite 1400, Cambridge, MA 02142, NDC: 59922-631-01.
Reason for recall
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
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-1389-2020. 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.