Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported July 22, 2020
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.
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Keryx Biopharmaceuticals, Inc. recalled Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured fo… - a moderate-severity action.
Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured fo… was recalled by Keryx Biopharmaceuticals, Inc. in July 22, 2020. Reason: cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing proce…. Check the official notice for the remedy. Verify recall #D-1389-2020 with the FDA Drug before acting.
The recall
Keryx Biopharmaceuticals, Inc. issued this moderate-severity FDA Drug recall-cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing proce….
- Moderate
- severity level
- Class II
- classification
- July 22, 2020
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1389-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1389-2020) was formally reported on July 22, 2020, with the manufacturer initiating the action on July 10, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Keryx Biopharmaceuticals, Inc. is listed as the recalling firm, operating out of Boston, MA. Federal records list the affected scope as 59,820 bottles.
The documented reason for this recall is: cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia. Distribution data in the federal record shows the product reached: Nationwide in the U.S.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
59,820 bottles
Related Recalls
6
0 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1389-2020 |
| Date reported | July 22, 2020 |
| Date initiated | July 10, 2020 |
| Recalling firm | Keryx Biopharmaceuticals, Inc. |
| Firm location | Boston, MA |
| Affected scope | 59,820 bottles |
| Distribution | Nationwide in the U.S. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1389-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Keryx Biopharmaceuticals, Inc.. Units affected: 59,820 bottles.
Why was this product recalled? ▼
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 22, 2020. Severity: Moderate. Recall number: D-1389-2020.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the U.S..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1389-2020) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported July 22, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.