thejoe First Royal Care Co. LLC, dba Red Moun

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy: 140 FDA recall reports

Every drug recall the FDA has published for First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy. The fault, and how the agency graded it.

140Reports

0Class I

0Ongoing

2021-11-03Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	140

By year reported

Year	Reports
2019	100
2021	40

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx

D-0041-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

D-0058-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx

D-0046-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx

D-0036-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx

D-0043-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

D-0037-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx

D-0050-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx

D-0035-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx

D-0031-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx

D-0042-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx

D-0067-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx

D-0048-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx

D-0039-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx

D-0034-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx

D-0038-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx

D-0053-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

D-0059-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx

D-0029-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx

D-0047-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx

D-0065-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx

D-0044-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

D-0057-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx

D-0045-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx

D-0051-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx

D-0055-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx

D-0028-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

D-0061-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx

D-0049-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx

D-0033-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx

D-0056-2022 · Class II · reported 2021-11-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Product: CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx
Where it went: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
How much: N/A

Showing the 30 most recent of 140. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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