Auryxia Ferric Citrate Tablets Recalled for Damaged Desiccant Packets
Keryx Biopharmaceuticals is recalling Auryxia (ferric citrate) tablets because damaged silica gel packets may allow desiccant granules to contact the medication.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard involves potential contact with desiccant granules, a packaging integrity issue rather than a direct toxicological threat.
Plain-English summary
Keryx Biopharmaceuticals, Inc. is recalling 2,488 bottles of Auryxia (ferric citrate) 210 mg tablets, 200-count bottles. The recall involves Lot # AH3842, which was distributed nationwide in the USA.
The recall was initiated due to reports of damaged StripPax packets containing silica gel desiccant. This damage potentially allows the silica gel granules to make contact with the Auryxia tablets inside the bottle.
Consumers should check their Auryxia bottles for Lot # AH3842. If the lot number matches, they should stop using the product and contact their healthcare provider or pharmacist for instructions on how to proceed.
The recalled product
- Product
- AURYXIA (FERRIC CITRATE)
- Brand
- AURYXIA
- Manufacturer
- Keryx Biopharmaceuticals, Inc.
- Category
- Drug — Prescription Drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # AH3842
Distribution
Distributed nationwide across the United States.
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