Agency classClass IIOur severity:High FDA (Drugs)·D-0049-2022·Announced 2021-11-03

Red Mountain Compounding Pharmacy Testosterone Blend Injection Sterility Recall

Red Mountain Compounding Pharmacy is recalling a testosterone-blend injection product due to FDA concerns about sterility assurance. The product was distributed to patients in seven states.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a risk-of-harm product (non-sterile injectable medication) with no reported illnesses or injuries documented in the source text. Per the rubric, recalls of this type score as High (3) because the hazard is significant—non-sterile injectable products pose a direct risk of infection—even though actual harm has not yet been reported.

Plain-English summary

Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) in sesame oil, an injectable drug product, due to lack of assurance of sterility. An FDA inspection identified concerns regarding the manufacturer's ability to ensure the product meets sterility requirements.

The recalled product was distributed to 494 patients and consumers who received prescriptions in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All lots within their expiration dating are affected by this recall.

Patients currently using this product should consult their healthcare provider or pharmacist for guidance. Do not use the product without speaking to a medical professional about appropriate alternative treatment options.

The recalled product

Product: TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Injectable / Compounded Medication
Hazard: sterility-assurance
injectable-contamination
infection-risk

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)

all lots within expiry

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 40 recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 40 products in this recall →

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

See all →

Severe
MIT/B12 Compounded Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
High
Testosterone Ultra 250MG/ML Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
Severe
Red Mountain Compounding Test Cypionate Sterility Assurance Recall
FDA (Drugs) · 2021-11-03
Severe
TEST CYP/PROP Compounded Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
High
TEST CYP 25MG/ML Injectable Lacks Assurance of Sterility
FDA (Drugs) · 2021-11-03

Same hazard · sterility assurance