# FDA recall D-0133-2018

> **Keryx Biopharmaceuticals, Inc.** · Class III · drug recall initiated 2017-12-12.

## Product

Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Biopharmaceticals, Inc. One Marina Park Drive, 12th Floor, Boston, MA 02210 USA. NDC 59922-631-01

## Reason for recall

Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.

## Distribution

Distributed nationwide in the USA

## Key facts

- **Recall number:** D-0133-2018
- **Recalling firm:** Keryx Biopharmaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-12-12
- **Report date:** 2018-01-03
- **Termination date:** 2018-10-01

- **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-0133-2018

## Citation

> AI Analytics. FDA recall D-0133-2018. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0133-2018. Source: US FDA. Licensed CC0.

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