Keryx Auryxia 210mg Tablets Recall: FDA Manufacturing Deviations
Keryx Biopharmaceuticals recalls Auryxia 210mg tablets due to FDA manufacturing process deviations. Affected lots were not made per approved standards. Consumers should contact Keryx for details.
Recall notice
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Contact the company
What happened, in plain English
Keryx Biopharmaceuticals is recalling Auryxia 210mg ferric citrate tablets because some batches were not made according to FDA-approved manufacturing procedures. This could mean the tablets may not be safe or effective as intended. Read more at govinfonow.com/recall/36946-keryx-auryxia-210mg-tablets-recall-fda-manufacturing-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/36946-keryx-auryxia-210mg-tablets-recall-fda-manufacturing-deviations · Updated October 5, 2026 · FDA enforcement record: FDA #D-1389-2020
Cite this page
“Keryx Auryxia 210mg Tablets Recall: FDA Manufacturing Deviations.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/36946-keryx-auryxia-210mg-tablets-recall-fda-manufacturing-deviations. Based on FDA recall #D-1389-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1389-2020%22&limit=1).
Why it’s dangerous
The recall is due to the FDA finding that some lots of Auryxia tablets were not made following the approved manufacturing process. This could mean the tablets might not be safe or effective as intended, but the exact risk to consumers is not specified in the recall notice.
Who’s affected
People who have the recalled Auryxia tablets (210mg, Rx Only, 200 tablets per bottle) from specific lots manufactured between 2020-2021 are affected. Prescriptions for these tablets are most at risk.
How to tell if you have this one
Check the product label for the brand name Keryx, product name Auryxia, and the specific lot numbers listed: AK6003C, AK6004B, CBMKF, CBMKH, CCKSM, CBWKN, CCSTZ, CCWZB, CCYSF, CCYSG, CCWZC, CDCTB, CDCSZ. The expiration dates range from August 2020 to July 2021.
- Brand
Keryx- Category
Drug
What to do — step by step
Check Product Details
Look for the lot numbers listed in the recall notice to confirm if your Auryxia tablets are affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the U.S.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1389-2020 (July 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1389-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.