The Recall Desk

Manufacturer

Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

2 recalls in our database name Akebia Therapeutics dba Keryx Biopharmaceutials, Inc as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2021-02-24

Of the 2 recalls from Akebia Therapeutics dba Keryx Biopharmaceutials, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • ModerateFDA (Drugs)·D-0260-2021·2021-02-24

    Auryxia Tablets Recalled for Failed Dissolution Specifications

    Akebia Therapeutics is recalling Auryxia (ferric citrate) tablets because they failed to meet dissolution specifications.

    Product
    Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0170-2021·2020-12-30

    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.

    Product
    AURYXIA — AURYXIA (FERRIC CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide