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North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding Recalls

All product recalls associated with North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding.

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Recall Summary

Total Recalls

1000

Past Year

295

Class I (Serious)

116

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 961–980 of 4465 recalls

LL-37 Injection (FarmaKeio) – Sterility Concerns (2022)

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Class IIModerate

FDAApr 5, 2022Nationwide• North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

BPC-157 Injection (FarmaKeio) – Sterility Concern (2022)

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Class IIModerate

FDAApr 5, 2022Nationwide• North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Melanotan II Injection (FarmaKeio) – Sterility Concern (2022)

1...47 484950 51...224

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Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Class IIModerate

FDAApr 5, 2022Nationwide• North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Ipamorelin/Sermorelin Injection (FarmaKeio) – Sterility Concern (2022)

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Class IIModerate

FDAApr 5, 2022Nationwide• North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Esomeprazole Magnesium Capsules (Mylan) – Impurity Specification (2022)

Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.

Class IIModerate

FDAApr 1, 2022Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Esomeprazole Magnesium Capsules (Mylan) – Impurity Specification Failure (2022)

Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.

Class IIModerate

FDAApr 1, 2022Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Abbott Vascular: Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, ...

There is a potential that the proximal marker may separate from the imaging catheter

FDAMar 30, 2022AL, AZ, AR +41 more• Abbott Vascular

Mandalorian Hand Sanitizer (Best Brands) – Benzene Contamination (2022)

Chemical Contamination; FDA analysis found product to contain benzene

Class IHigh

FDAMar 29, 2022Nationwide• Best Brands Consumer Products, Inc.

Mickey Mouse Hand Sanitizer (Best Brands) – Methanol Contamination (2022)

Chemical Contamination; FDA analysis found product to contain methanol

Class IHigh

FDAMar 29, 2022Nationwide• Best Brands Consumer Products, Inc.

Stryker GmbH Bohnackerweg 1 Selzach Switzerland: Smart Toe II Intramedullary Arthrodesis Implant

The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity".

FDAMar 28, 2022Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

Becton, Dickinson and Company, BD Biosciences: BD Anti-Kappa APC (Cat. No. 341098) is an analyte specifi...

Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.

FDAMar 25, 2022Nationwide• Becton, Dickinson and Company, BD Biosciences

Becton, Dickinson and Company, BD Biosciences: BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific...

Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.

FDAMar 25, 2022Nationwide• Becton, Dickinson and Company, BD Biosciences

Abbott: Abbott SE TactiCath Sensor Enabled Contact Force Ablation...

Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.

FDAMar 24, 2022Nationwide• Abbott

Varian Medical Systems Imaging Laboratory GmbH Tafernstrasse 7 DATTWIL Baden Switzerland: ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15...

Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location

FDAMar 21, 2022Nationwide• Varian Medical Systems Imaging Laboratory GmbH Tafernstrasse 7 DATTWIL Baden Switzerland