Auryxia (Ferric Citrate) Recall: Failed Dissolution Specs
Keryx Biopharmaceuticals recalls Auryxia tablets due to failed dissolution specifications. Check lot numbers CDKSN, CDPPH, and CDPPK for expiration dates in Jan/Feb 2022.
Use caution until it’s fixed
Failed Dissolution Specifications
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What happened, in plain English
Keryx Biopharmaceuticals is recalling specific lots of Auryxia (ferric citrate) tablets because they failed dissolution specifications. This means the medication may not release or absorb properly, potentially affecting its effectiveness. The recall affects 17,664 bottles distributed nationwide. Read more at govinfonow.com/recall/36539-auryxia-ferric-citrate-recall-failed-dissolution-specs.
Source Summary by GovInfoNow · govinfonow.com/recall/36539-auryxia-ferric-citrate-recall-failed-dissolution-specs · Updated October 11, 2026 · FDA enforcement record: FDA #D-0260-2021
Cite this page
“Auryxia (Ferric Citrate) Recall: Failed Dissolution Specs.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36539-auryxia-ferric-citrate-recall-failed-dissolution-specs. Based on FDA recall #D-0260-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0260-2021%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications, which is a quality control test ensuring the drug breaks down correctly in the body. If the medication does not dissolve as intended, it may not be absorbed effectively, leading to subtherapeutic dosing for patients who rely on it.
Who’s affected
Patients prescribed Auryxia for iron management who possess specific lots of the 210 mg tablets in 200-count bottles. Individuals with lot numbers CDKSN, CDPPH, or CDPPK are most at risk.
How to tell if you have this one
Look for Auryxia (ferric citrate) tablets, 210 mg, in 200-tablet bottles with an RX ONLY label. Check the lot numbers and expiration dates: Lot CDKSN (Exp Jan 2022), Lot CDPPH (Exp Jan 2022), and Lot CDPPK (Exp Feb 2022). The NDC is 59922-0631-01.
- Brand
Auryxia- Category
Drug
What to do — step by step
Check your medication
Verify if your Auryxia bottle matches the recalled lot numbers (CDKSN, CDPPH, or CDPPK) and expiration dates (January or February 2022).
Contact your pharmacist
Speak with your healthcare provider or pharmacist to determine if you have a recalled product and how to replace it.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-0260-2021 (January 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0260-2021 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.