Testosterone Ultra 250MG/ML Recalled for Sterility Assurance Concerns
First Royal Care Co. LLC, operating as Red Mountain Compounding Pharmacy, is recalling Testosterone Ultra 250MG/ML in sesame oil due to lack of assurance of sterility identified during FDA inspection.
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 for a sterile compounded injectable drug product. Lack of sterility assurance in an injectable poses direct risk of serious harm (infection, sepsis, or other life-threatening conditions) even though no illnesses have been reported in the source text. The hazard is not theoretical—sterility failures in injectables can cause serious injury.
Plain-English summary
First Royal Care Co. LLC, operating as Red Mountain Compounding Pharmacy, is recalling Testosterone Ultra 250MG/ML MDV in sesame oil (prescription only) because FDA inspection raised concerns about sterility assurance of the product.
The recall affects 494 patients and consumers in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah who received prescriptions for this product. All lots still within expiry are included in this recall.
Patients currently using this product should contact their healthcare provider or pharmacy for guidance. Consumers should not use remaining supplies without consulting a healthcare professional.
The recalled product
- Product
- TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-assurance
- contamination-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
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