Auryxia (ferric citrate)

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Failed Dissolution Specifications

The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.

What was recalled

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.

Affected NDC 59922-0631-01

Compare with the code on your package — it is the most precise check available.

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

Product	Strength	Form & route	Labeler	Type
Auryxia ferric citrate NDC 59922-0631	TETRAFERRIC TRICITRATE DECAHYDRATE 210 mg/1	Tablet, Film Coated Oral	Akebia Therapeutics, Inc.	Rx

Recalling firm: Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
NDC code: 59922-0631-01
Origin: MA, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-0260-2021 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other recalls by Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

All 2021 recalls

Dec 9, 2020 Class II · Moderate risk