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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Keryx Biopharmaceuticals, Inc.: Auryxia (ferric citrate) Tablets Recalled for Potential Foreign Substance

Agency Publication Date: December 26, 2017
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Summary

Keryx Biopharmaceuticals is recalling 2,488 bottles of Auryxia (ferric citrate) 210 mg tablets because damaged moisture-absorbing packets (StripPax) inside the bottles may have leaked silica gel granules. These granules can come into direct contact with the tablets, creating a foreign substance contamination issue. This recall affects 200-count bottles from lot number AH3842 that were distributed nationwide in the United States.

Risk

If the silica gel granules from a damaged desiccant packet are accidentally ingested along with the medication, they may pose a choking hazard or cause digestive irritation, though the risk level is currently classified as low.

What You Should Do

  1. Check your prescription bottle of Auryxia (ferric citrate) 210 mg tablets (200-count) for Lot # AH3842 and NDC 59922-631-01.
  2. Inspect the inside of the bottle for any loose, clear, or white granules that may have leaked from the desiccant packet.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you find your bottle is from the affected lot or if you see loose granules.
  4. Return any unused medication from the affected lot to your pharmacy for a refund.
  5. Contact Keryx Biopharmaceuticals directly for further instructions regarding this recall.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles
Model:
NDC 59922-631-01
Recall #: D-0133-2018
Lot Numbers:
AH3842

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78773
Status: Resolved
Manufacturer: Keryx Biopharmaceuticals, Inc.
Sold By: pharmacies
Manufactured In: United States
Units Affected: 2,488 200-bottles
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.