FDA Drug recall D-0133-2018
Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Biopharmaceticals, Inc
- FDA Drug
- Class III
- terminated
- Published 2018-01-03
On 2018-01-03 the FDA classified a Class III recall of Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Biopharmaceticals, Inc by Keryx Biopharmaceuticals, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0133-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-12-12 |
| Published | 2018-01-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Keryx Biopharmaceuticals |
| Distribution | US |
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
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.
Identifiers
| ndc | 59922-631-01 |
|---|---|
| code_info | Lot # AH3842 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0133-2018%22
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