Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc FDA Record
- No warning letters matched by name
Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc has 2 FDA recalls, 0 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc" is on file.
- Latest recall
- D-0260-2021 · Class III · Jan 29, 2021
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 2 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 0 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc: FDA recall records per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 1 | 0 |
| 2020 | 0 | 0 | 0 | 1 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0260-2021 | Class III | Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and… | Jan 29, 2021 |
| D-0170-2021 | Class II | Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and… | Dec 9, 2020 |
Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc and the FDA: common questions
Has Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc received an FDA warning letter?
No FDA warning letter addressed to the name "Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc received an FDA Form 483?
FDA has not published a Form 483 for "Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc" in its reading room. FDA publishes some Form 483s, not all of them.
Has Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc had an FDA recall?
Yes. Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc has 2 FDA recalls on record. The most recent started Jan 29, 2021.
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