Methylcobalamin injection recalled due to sterility assurance concerns
Red Mountain Compounding Pharmacy is recalling a methylcobalamin injectable solution after FDA inspection raised concerns about the lack of assurance of sterility.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text indicates a sterility assurance concern raised during inspection but does not report any actual illnesses, injuries, or adverse events. The hazard is investigational/precautionary rather than confirmed.
Plain-English summary
First Royal Care Co. LLC, operating as Red Mountain Compounding Pharmacy, is recalling METHYLCOBALAMIN 12.5MG/ML MDV (multi-dose vial) injectable solution, prescription only. The recall was initiated following an FDA inspection that raised sterility assurance concerns regarding the product.
The product was distributed to 494 patients/consumers who received prescriptions. Distribution occurred across Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All affected lots are still within expiration dating.
Consumers who have received this product should consult their healthcare provider or pharmacist regarding continued use of the recalled medication. The lack of adequate sterility assurance in an injectable solution poses a potential risk that should be addressed with medical guidance.
The recalled product
- Product
- METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx
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
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 →Related recalls
Same manufacturer · First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
See all →- SevereMIT/B12 Compounded Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- HighTestosterone Ultra 250MG/ML Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- SevereRed Mountain Compounding Test Cypionate Sterility Assurance Recall
FDA (Drugs) · 2021-11-03
- SevereTEST CYP/PROP Compounded Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- HighTEST CYP 25MG/ML Injectable Lacks Assurance of Sterility
FDA (Drugs) · 2021-11-03
Same hazard · sterility assurance
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
- SevereArrow drainage and thoracentesis kits contain recalled supplier drugs
FDA (Devices) · 2026-06-24