Auryxia — Class III drug recall D-0133-2018
Terminated recall by Keryx Biopharmaceuticals, Inc., reported 2018-01-03, distributed nationwide. Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel de
| Recall number | D-0133-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Keryx Biopharmaceuticals, Inc., Boston, MA, United States |
| Recall initiated | 2017-12-12 |
| Classified | 2017-12-26 |
| Reported by FDA | 2018-01-03 |
| Terminated | 2018-10-01 |
| Distributed | Nationwide (US) |
| NDC | 59922-0631, 59922-0631-01 |
| Lot numbers | AH3842 |
Product
Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Biopharmaceticals, Inc. One Marina Park Drive, 12th Floor, Boston, MA 02210 USA. NDC 59922-631-01
Reason for 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0133-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.