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First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Recalls

All product recalls associated with First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy.

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Recall Summary

Total Recalls

1000

Past Year

566

Class I (Serious)

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 3901–3920 of 7756 recalls

S-Calm Injection (Red Mountain) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Hydroxocobalamin High-Dose Injection (Red Mountain) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Implant Direct Sybron Manufacturing, LLC: Implant Direct, REF: 833708, Legacy 2 Implant, Surface: H...

A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.

1...194 195196197 198...388

Page 196 of 388Next

FDAAug 9, 2019IN, MD, TX +2 more• Implant Direct Sybron Manufacturing, LLC

Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland: Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Numb...

The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.

FDAAug 9, 2019Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland: Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF...

FDAAug 9, 2019Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

BioFire Diagnostics, LLC: FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-010...

Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.

FDAAug 8, 2019IL, KY, MS +1 more• BioFire Diagnostics, LLC

MOTEK MEDICAL B.V. Hogehilweg 18 18 Unit C Amsterdam Netherlands: Body Weight Support (BWS) Light; Model No. RB011; a compo...

The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable guide.

FDAJul 29, 2019Nationwide• MOTEK MEDICAL B.V. Hogehilweg 18 18 Unit C Amsterdam Netherlands

Bexarotene Capsules (Upsher Smith) – Dissolution Failure (2019)

Failed Dissolution Specifications

Class IIModerate

FDAJul 29, 2019KY, LA, NJ +1 more• Upsher Smith Laboratories, Inc.

Stryker GmbH Bohnackerweg 1 Selzach Switzerland: Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF...

The seal integrity of the sterile bag containing the kits may be compromised.

FDAJul 25, 2019Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland: Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 -...

Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.

FDAJul 25, 2019Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Stryker GmbH Bohnackerweg 1 Selzach Switzerland: Endotrac ECTR Hook Blade, Catalog Number 2055-1 The E...

The seal integrity of the sterile bag containing the kits may be compromised.

FDAJul 25, 2019Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

Stryker GmbH Bohnackerweg 1 Selzach Switzerland: Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054...

The seal integrity of the sterile bag containing the kits may be compromised.

FDAJul 25, 2019Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

Stryker GmbH Bohnackerweg 1 Selzach Switzerland: Endintrak 2 Hook Blade, Angled, Catalog Number 4058A-1 ...

The seal integrity of the sterile bag containing the kits may be compromised.

FDAJul 25, 2019Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

Stryker GmbH Bohnackerweg 1 Selzach Switzerland: Endotrac ECTR Triangle Blade, Catalog Number 2054-1 T...

The seal integrity of the sterile bag containing the kits may be compromised.

FDAJul 25, 2019Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

Stryker GmbH Bohnackerweg 1 Selzach Switzerland: Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 Th...

The seal integrity of the sterile bag containing the kits may be compromised.

FDAJul 25, 2019Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

Stryker GmbH Bohnackerweg 1 Selzach Switzerland: Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 ...

The seal integrity of the sterile bag containing the kits may be compromised.

FDAJul 25, 2019Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

Stryker GmbH Bohnackerweg 1 Selzach Switzerland: Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-1 ...

The seal integrity of the sterile bag containing the kits may be compromised.

FDAJul 25, 2019Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

Fresh Basil (Rock Garden) – Cyclospora contamination (2019)

Fresh basil received from supplier is potentially contaminated with Cyclospora.

Class IIModerate

FDAJul 25, 2019Nationwide• Herbs Unlimited d/b/a Rock Garden South

Stryker GmbH Bohnackerweg 1 Selzach Switzerland: Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 Th...

The seal integrity of the sterile bag containing the kits may be compromised.

FDAJul 25, 2019Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

Stryker GmbH Bohnackerweg 1 Selzach Switzerland: Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A...

The seal integrity of the sterile bag containing the kits may be compromised.

FDAJul 25, 2019Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland