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Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

Akebia Therapeutics dba Keryx Biopharmaceutials, Inc Recalls

All product recalls associated with Akebia Therapeutics dba Keryx Biopharmaceutials, Inc.

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Recall Summary

Total Recalls

1000

Past Year

888

Class I (Serious)

124

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 5401–5420 of 17593 recalls

Auryxia (Akebia) – dissolution failure (2021)

Failed Dissolution Specifications

Class IIILow

FDAJan 29, 2021Nationwide• Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

Duodenoscope (Olympus) – Mucosal Injury Risk (2021)

Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, including the distal cover (model MAJ- 2315).

High

FDAJan 28, 2021Nationwide• Olympus Corporation of the Americas

Protein Fiber Oatmeal (Glanbia Performance Nutrition) – undeclared nuts (2021)

Undeclared Allergen

Undeclared ingredients including but not limited to pecans and almonds

1...269 270271272 273...880

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Class IIModerate

FDAJan 28, 2021Nationwide• Glanbia Performance Nutrition (Manufacturing), Inc

Spironolactone Tablets (Bryant Ranch) – Label Mix-Up (2021)

Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.

Class IIModerate

FDAJan 27, 2021Nationwide• Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Spironolactone Tablets (Bryant Ranch) – Label Mix-Up (2021)

Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.

Class IHigh

FDAJan 27, 2021Nationwide• Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Corin BIOLOX DELTA Mod Head 36mm (Corin) – Labeling Error (2021)

The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa.

Low

FDAJan 25, 2021Nationwide• Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom

Corin BIOLOX DELTA Mod Head 32mm (Corin) – Labeling Error (2021)

Low

FDAJan 25, 2021Nationwide• Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom

Barco MDNC-3421 Display (Barco) – DICOM Non-Compliance (2021)

A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.

Moderate

FDAJan 22, 2021WI• Barco N.V. President Kennedypark 35 Kortrijk Belgium

RayStation Software (RaySearch) – Software Calculation Bug (2021)

A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose statistics for an incorrectly created ROI are used to determine if a plan is acceptable for treatment, this could potentially lead to an inappropriate plan being approved. The error could lead to a more conservative or more liberal plan than intended.

Moderate

FDAJan 22, 2021AZ, CA, GA +1 more• RaySearch America Inc

Kodama Ultrasound Catheter (Acist) – O-Ring Damage (2021)

Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potential to be flushed out of the catheter. ACIST is confirming the source of the failure mode to assure the quality and reliability of the Kodama catheter. There have been no related field reports related to this incident, nor any evidence or report of patient injury or adverse health consequence.

Moderate

FDAJan 22, 2021Nationwide• Acist Medical Systems

Orthodontic Elastic Band (G & H Wire) – Packaging Error (2021)

The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does not expect device failures; Instead, there is an opportunity for misuse of the device if the label is not read. If the band is too small, the treatment may be more aggressive. It is important to note that elastic band force decreases over time. If the band is too small and still applied, the band could break. Both circumstances could result in temporary patient discomfort.

Moderate

FDAJan 21, 2021Nationwide• G & H Wire Company

Dutchmen Voltage (Dutchmen) – Label Incorrect (2021)

Keystone RV Company (Keystone) is recalling certain 2020-2021 Dutchmen Voltage 3001, 3351, 3521, 3531, 3551, 3571, 3951 and 4271 recreational trailers. The Federal Identification Tag incorrectly lists the recommended tire pressure as 110 PSI, instead of the correct tire pressure of 95 PSI. As such, these vehicles fail to comply with the requirements of 49 CFR Part 567, "Certification."

Moderate

NHTSAJan 21, 2021Nationwide• DUTCHMEN

Dutchmen Voltage (Dutchmen) – Identification Tag Error (2021)

Keystone RV Company (Keystone) is recalling certain 2021 Dutchmen Voltage 3915 and 4225 recreational trailers. The Federal Identification Tag incorrectly lists the recommended tire pressure as 95 PSI, instead of the correct tire pressure of 110 PSI. As such, these vehicles fail to comply with the requirements of 49 CFR Part 567, "Certification."

Moderate

NHTSAJan 21, 2021Nationwide• DUTCHMEN

Lidocaine/Tetracaine Ointment (Stanley) – Superpotent Drug (2021)

Superpotent Drug. Lidocaine higher concentration than listed

Class IIModerate

FDAJan 21, 2021Nationwide• Stanley Specialty Pharmacy Compounding and Wellness Center

SARS-CoV-2 Antibody Test (Sky Medical) – Authorization Violation (2021)

Distributed COVID test kits without emergency use authorization.

Moderate

FDAJan 19, 2021Nationwide• Sky Medical Supplies and Equipments LLC

HeartSpan Transseptal Needles (Merit Medical) – Tip Curvature Mismatch (2021)

The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to require medical intervention.

Moderate

FDAJan 19, 2021AL, CA, CT +15 more• Merit Medical Systems, Inc.

Roasted Pistachios (Horizon) – Chemical Excess (2021)

Product may have low levels of imidacloprid in excess of the tolerance of 0.05 ppm.

Class IIILow

FDAJan 17, 2021CA, MN• Horizon Nut Company, LLC

Chocolate Milk (Hiland) – Sanitizer Contamination (2021)

Milk contaminated with food grade sanitizer

Class IIModerate

FDAJan 17, 2021OK, TX• Hiland Dairy Foods Company, LLC

Benzphetamine Tablets (Calvin Scott) – Label Mix-Up (2021)

Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.

Class IIILow

FDAJan 15, 2021GA, IN• Calvin Scott & Company, Inc.

Classic Chocolate Bar Library (Lake Champlain) - plastic contamination (2021)

Chocolate may contain plastic pieces

Class IIModerate

FDAJan 15, 2021Nationwide• Champlain Chocolate Company