Keryx recalls Auryxia 210mg tablets due to CGMP deviations
Keryx Biopharmaceuticals recalls 200-count Auryxia (ferric citrate) tablets with CGMP deviations. This prescription medication may have manufacturing issues affecting quality.
Recall notice
CGMP Deviations
Contact the company
What happened, in plain English
Keryx Biopharmaceuticals is recalling 200-count bottles of Auryxia (ferric citrate) tablets that were manufactured with CGMP deviations. This recall is for prescription-only medication that could have quality issues from manufacturing. Read more at govinfonow.com/recall/36618-keryx-recalls-auryxia-210mg-tablets-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/36618-keryx-recalls-auryxia-210mg-tablets-due-to-cgmp-deviations · Updated October 4, 2026 · FDA enforcement record: FDA #D-0170-2021
Cite this page
“Keryx recalls Auryxia 210mg tablets due to CGMP deviations.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36618-keryx-recalls-auryxia-210mg-tablets-due-to-cgmp-deviations. Based on FDA recall #D-0170-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0170-2021%22&limit=1).
Why it’s dangerous
CGMP deviations refer to manufacturing process issues that could affect the quality and safety of the medication. This means the tablets might not meet the required standards for purity and effectiveness.
Who’s affected
Prescription patients who have the 200-count bottles of Auryxia (ferric citrate) tablets with lot number 9062. Patients using this medication for iron deficiency anemia are most at risk.
How to tell if you have this one
Check for the 200-count bottles of Auryxia (ferric citrate) tablets with lot number 9062. The product is prescription-only and distributed by Keryx Biopharmaceuticals.
- Brand
Keryx- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number 9062 on the bottle to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “The product was distributed by two major distributors who further distributed the product nationwide and one specialty pharmacy.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 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-0170-2021 (December 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0170-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.