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.
What this means for you
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
- 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:
- AZ
- CA
- FL
- MN
- MT
- TX
- UT
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- ModerateGas-X Simethicone 125 mg softgels recall for incomplete labeling
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27