Keryx Auryxia tablets recall: Silica gel risk in bottles
Keryx recalls 210mg Auryxia tablets (200-count) due to silica gel desiccant potentially contacting tablets. RX-only medication for iron deficiency.
Lower-risk recall
Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
Contact the company
What happened, in plain English
Keryx is recalling 210mg Auryxia iron tablets (200-count bottles) because silica gel desiccant packets inside the bottles might contact the tablets. This could cause the tablets to become unsafe for use. Read more at govinfonow.com/recall/41023-keryx-auryxia-tablets-recall-silica-gel-risk-in-bottles.
Source Summary by GovInfoNow · govinfonow.com/recall/41023-keryx-auryxia-tablets-recall-silica-gel-risk-in-bottles · Updated October 7, 2026 · FDA enforcement record: FDA #D-0133-2018
Cite this page
“Keryx Auryxia tablets recall: Silica gel risk in bottles.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41023-keryx-auryxia-tablets-recall-silica-gel-risk-in-bottles. Based on FDA recall #D-0133-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0133-2018%22&limit=1).
Why it’s dangerous
Silica gel desiccant packets inside the bottle could contact the tablets, potentially causing the tablets to become unsafe. This is a foreign substance risk that may affect the medication's safety.
Who’s affected
Prescription patients using Auryxia tablets for iron deficiency. Those with silica gel desiccant packets in the bottle are most at risk.
How to tell if you have this one
Check for 210mg Auryxia tablets in 200-count bottles with NDC 59922-631-01. The bottles were manufactured with silica gel desiccant packets that could contact the tablets.
- Brand
Keryx- Category
Drug
What to do — step by step
Check for Silica Gel Packets
Look for silica gel desiccant packets inside the bottle that might have contacted the tablets.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 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-0133-2018 (December 12, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0133-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.