Akebia Recalls Auryxia Tablets Due to Manufacturing Deviations
Akebia Therapeutics is voluntarily recalling 2,170 bottles of Auryxia (ferric citrate) tablets due to CGMP deviations. The FDA classified this as a Class II recall.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as a Class II recall, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The rubric maps Class II recalls without specific hospitalization reports to a High severity score.
Plain-English summary
Akebia Therapeutics dba Keryx Biopharmaceutials, Inc. is voluntarily recalling 2,170 bottles of Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles. The recall was initiated on December 9, 2020, and was classified by the FDA as Class II. The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations.
The affected product is identified by Lot Number 9062 with an expiration date of February 2021. The product is a prescription-only medication manufactured for and distributed by Keryx Biopharmaceuticals, Inc. The NDC for the product is 59922-631-01.
The product was distributed nationwide by two major distributors and one specialty pharmacy. The recall was terminated on September 1, 2021. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above and contact their pharmacist or the manufacturer for further instructions.
The recalled product
- Product
- AURYXIA (FERRIC CITRATE)
- Brand
- AURYXIA
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 2,170
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number: 9062
- exp. date Feb 2021
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · AURYXIA
- ModerateCardinal Health Recalls Auryxia Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- ModerateKeryx Recalls Auryxia Tablets Due to Manufacturing Process Deviations
FDA (Drugs) · 2020-07-22
- LowAuryxia Ferric Citrate Tablets Recalled for Damaged Desiccant Packets
FDA (Drugs) · 2018-01-03
Same manufacturer · Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
See all →- ModerateAuryxia Tablets Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2021-02-24
Same hazard · cgmp deviations
See all →- ModerateFentanyl Citrate Injectable Solution Recall Due to cGMP Deviations
FDA (Drugs) · 2026-05-06
- ModerateGlenmark Lacosamide 100mg Tablets Recalled for CGMP Deviations
FDA (Drugs) · 2025-04-16
- ModerateGlenmark Pharmaceuticals Recalls Pravastatin Sodium Tablets 80mg
FDA (Drugs) · 2025-04-16
- ModerateMigrenol Caplet Drug Recalled for CGMP Deviations
FDA (Drugs) · 2022-02-16
- ModerateDrug Recall: APAP 500 mg Phenyl HCl Tablets for CGMP Deviations
FDA (Drugs) · 2022-02-16