# FDA recall D-1389-2020

> **Keryx Biopharmaceuticals, Inc.** · Class II · drug recall initiated 2020-07-10.

## Product

Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc., 245 First Street Suite 1400, Cambridge, MA 02142, NDC: 59922-631-01.

## Reason for recall

cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.

## Distribution

Nationwide in the U.S.

## Key facts

- **Recall number:** D-1389-2020
- **Recalling firm:** Keryx Biopharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-07-10
- **Report date:** 2020-07-22
- **Termination date:** 2021-01-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Boston, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1389-2020

## Citation

> AI Analytics. FDA recall D-1389-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-1389-2020. Source: US FDA. Licensed CC0.

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